MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,health professional, report with the FDA on 2015-07-10 for ANCHOR BOLT 2103-29-25MM manufactured by Pmt Corp..
[6051482]
Medwatch was received on 07/01/2015 at pmt corporation regarding an event that occurred on (b)(6) 2015 at (b)(6) hospital. Pmt corporation was attempting to gather more information when this medwatch was received. A complaint file has been initiated. Here is the narrative from the medwatch received from (b)(6) hospital: "the bolt was too short, then too long, needed a thicker one and used pmt bolt; screwed down 6 turns as instructed and transgressed too far into intradural. Could not see distal end, opened via craniotomy to retrieve. Manufacturer response for pmt bolt, anchor bolt (per site reporter). " "prior use of ad-tech screw may have increased the size of the twist hole. " "what was the original intended procedure" stereotactic electrodes placement. "
Patient Sequence No: 1, Text Type: D, B5
[14203206]
This is an initial report completed by pmt corporation. An investigation has not been finalized as the product has not been returned to pmt corporation. The customer has not responded to attempts to gather more information. Once, or if, additional information is received, pmt corporation will file a follow-up form 3500a. Preliminary information shows user error.
Patient Sequence No: 1, Text Type: N, H10
[69250087]
The following information was received by pmt corporation from the risk manager that filed the medwatch at emory university hospital. "a medtech representative was also in the room during the procedure, along with a pmt corporation representative. She stated that they were told to turn the anchor bolt only six times and went too far. The device is not going to be returned to pmt. " a pmt representative gave the following statement when pmt's quality manager approached the subject. "an adtech drill bit was used. After making it through the skull and the dura, they were putting a 2. 4mm pmt anchor bolt into the skull. Before the resident started to tighten the bolt, i informed him that six easy turns would be enough to tighten the bolt. He then proceeded to turn the driver at least twice that amount and in turn the bolt was too far in the skull to allow our cap to be placed on the bolt. They decided to take pmt's anchor bolt out and place an adtech bolt on the same hole. The adtech bolt is a larger diameter which obviously made the hole bigger. The resident then screwed this bolt too far down as well not allowing the cap to be above the scalp. They removed this bolt and decided to put the pmt bolt back into the same hole that is now much bigger than the original. When the resident went to place the bolt, there was nothing for the bolts threads to grab onto and he ended up plunging the bolt. " pmt concludes that the cause of the injury was caused by the resident widening the hole using an ad-tech anchor bolt. Then trying to use a smaller pmt anchor bolt, when the ad-tech one didn't work. The anchor bolts are not designed to work in conjunction with one another or be interchangeable. The resident physician did not adhere to the recommendations of the pmt representative to turn the bolt only six times. This is a user error. No product malfunction can be determined by the information received from the customer and our representative present during the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182979-2015-00002 |
| MDR Report Key | 4911590 |
| Report Source | 00,05,06,HEALTH PROFESSIONAL, |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-10 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KIM SCHMELZER |
| Manufacturer Street | 1500 PARK RD. |
| Manufacturer City | CHANHASSEN MN 55317 |
| Manufacturer Country | US |
| Manufacturer Postal | 55317 |
| Manufacturer Phone | 9524700866 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT |
| Generic Name | ANCHOR BOLT |
| Product Code | GZL |
| Date Received | 2015-07-10 |
| Model Number | 2103-29-25MM |
| Catalog Number | 2103-29-25MM |
| Lot Number | 030215 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | I |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PMT CORP. |
| Manufacturer Address | 1500 PARK RD. CHANHASSEN MN 55317 US 55317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-10 |