MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-18 for ANCHOR BOLT-LSB STYLE LSBK1-AX-05 manufactured by Ad-tech Medical Instrument Corp..
[106019809]
As stated in the event description section, ad-tech responded back to the customer the day they were notified to obtain additional information. To date, the customer has not responded back. Thus, it is unknown what the outcome/current status is of the patient. An internal complaint investigation was performed for this issue. Specifically, a historical complaints review was completed for the alleged deficiency "broken anchor bolts". There have been (b)(4) similar complaints for anchor bolts breaking between (b)(4)2016 and (b)(4) 2018. A capa and investigation review was also conducted for the alleged deficiency "anchor bolt broke after implantation" and there have been no capas or investigations opened for this issue to date. Two lot numbers (lot 208140643 or 208140644) were listed. This is due to the customer being unsure of the specific lot number for the impacted bolt. Based on this, 2 batch record reviews were performed for the impacted product on 4/6/2018 (for lot 208140644, batch# 109669) and 4/13/2018 (for lot 208140643, batch# 110042). Specific to batch# 109669, (b)(4) anchor bolts were planned for this work order and 33 were completed. There were no additional issues noted in the work order process notes that would contribute to the reported complaint and all kits passed the in-process and final qc checks. Specific to batch# 110042, (b)(4) anchor bolts were planned for this work order and 71 were completed (2 anchor bolts from this batch were nonconforming unrelated to this issue). There were no additional issues noted in the work order process notes that would contribute to the reported complaint and all kits passed the in-process and final qc checks. (b)(4). The product was returned to ad-tech on 3/29/2018 and a return analysis was completed. The anchor bolt was received in a used and contaminated condition with no evidence of successful sterilization. A visual examination was performed through the packaging in which the product was received. The anchor bolt body was found to be broken into two pieces. The point of breakage was in the threaded area that would screw into the skull. Based on this information, the complaint return evaluation does support the reported alleged deficiency. A risk assessment was performed and the risk level is considered alap (as low as possible). The investigation is still on-going as ad-tech is awaiting further information from the distributor/customer.
Patient Sequence No: 1, Text Type: N, H10
[106019810]
On 3/19/2018, the ad-tech clinical specialist received an email from a distributor stating that they were informed by one of their customers that an ad-tech anchor bolt broke after implantation. Ad-tech responded back to the customer that day to obtain additional information to help aid with the complaint investigation. To date, the customer has not responded back. It is unknown what the outcome or current status is of the patient. A supplement report will be initiated should ad-tech receive additional information relevant to this medwatch report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2018-00001 |
| MDR Report Key | 7441803 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-18 |
| Date of Report | 2018-09-20 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2017-05-24 |
| Date Added to Maude | 2018-04-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KATHLEEN BARLOW |
| Manufacturer Street | 400 OAKVIEW PKWY |
| Manufacturer City | OAK CREEK WI 53154 |
| Manufacturer Country | US |
| Manufacturer Postal | 53154 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 OAKVIEW PKWY |
| Manufacturer City | OAK CREEK WI 53154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT-LSB STYLE |
| Generic Name | ANCHOR BOLT-LSB STYLE |
| Product Code | GCZ |
| Date Received | 2018-04-18 |
| Returned To Mfg | 2018-03-29 |
| Catalog Number | LSBK1-AX-05 |
| Lot Number | 208140643 OR 208140644 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 OAKVIEW PKWY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-18 |