MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T25 STARDRIVE SHAFT F/MATRIX STANDARD; SCREWDRIVERS

Catalog Number	03.632.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a hardware removal of an unknown matrix screw at the lumbar due to loosening of the screw.During the surgery, when the surgeon tried to remove the screw, the screwdriver shaft stardrive t25 tip broke off.The surgery was finished without any other problem although it was not reported how the surgery was completed.There were no broken parts remaining in the patient's body, confirmed by x-ray.There was less than 30 minutes of surgical delay but no adverse consequence to the patient reported.Concomitant devices: matrix screw (part: unknown, lot: unknown, quantity: 1).This report is for a t25 stardrive shaft for matrix standard.This is report 1 of 1 for (b)(4) and captures the intraoperative event.The loosening of the unknown matrix screw is captured under (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the tip of the received screwdriver is broken off, three fragments were generated which is also visible on the picture from the customer.All fragments were returned for evaluation.The forefront of the t25 is in a used condition, the edges are worn and there is a slight burr at the forefront.The dimensions cannot be verified anymore due to the damage of the tip with the three fragments.The complaint condition is confirmed as the tip of the screwdriver is broken as complained.Due to the age and the used condition of the device a manufacturing related issue can be excluded.Based on the provided information the exact cause of this occurrence cannot be defined.It can only be assumed that a mechanical overload during the loosening of a locking cap caused the breakage.In this relation we would like to mention to locking cap removal section of the corresponding surgical technique.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part # 03.632.002, synthes lot number: 6543874, release to warehouse date: 07-mar-2011, manufacturing site: synthes monument, no ncr¿s were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T25 STARDRIVE SHAFT F/MATRIX STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8700127
• Report Number: 8030965-2019-65322
• Device Sequence Number: 1942129
• Product Code: HXX
• UDI-Device Identifier: 07611819378063
• UDI-Public: (01)07611819378063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.632.002
• Device Lot Number: 6543874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS