MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-09-13 for THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM N/A 91-6704 manufactured by Biomet Microfixation.
[120153600]
(b)(4). Device product code: hbw. (b)(4). Foreign country: (b)(6). Customer has indicated that the head of the screw is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[120153601]
It was reported that during a "opturo cranium" procedure "one screw fractured during the procedure and retained the fragment in the patient body. " the other screws worked without trouble and the surgery was completed. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[134391771]
Complaint sample was evaluated and the reported event was confirmed. The 1. 5x4mm x-drive tf sd screw ea (part# 91-6704, lot# unk) was visually evaluated. The screw showed obvious signs of use, as it was fractured at the shaft of the screw, near where the fluted section begins at the head. The cross-drive head slots also showed signs of wear. No functional testing was done on the screw as it was clearly fractured. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. There are no indications of manufacturing defects. Investigation results concluded that the reported event was due to excessive force applied beyond what the screw is designed to encounter during insertion. The doctor said the bone density was normal, however, there was no measurable data so the screw insertion attempt may have been into high density bone. The instructions for use (ifu) for this screw states in the section titled 'warnings': intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws. It also states in the section titled 'bone screws': incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver. Excessive torque can cause the screw to fracture. Self drilling screws may fracture, bend or break if used in a bicortical application. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[134391772]
This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00623 |
| MDR Report Key | 7873292 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-09-13 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-08-19 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2018-09-13 |
| 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. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-10-08 |
| Model Number | N/A |
| Catalog Number | 91-6704 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-09-13 |