MAUDE Adverse Event Report: SYNTHES GMBH COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW; GUIDE

Catalog Number	03.226.016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2021, the patient underwent open reduction internal fixation (orif) for a distal radius fracture.Implant insertion was completed without any problem, and then a metal fragment was found near the screw insertion site during cleaning before wound closure.The fragment was removed.It may be a fragment of the drill bit, sleeve, or screwdriver shaft.X-ray was performed and confirmed that no other fragments were present.The surgery was completed successfully with no delay.This report is for a compression sleeve.This is report 2 of 3 for (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.Updated data: d4, h4.Investigation summary: according to the information received the patient underwent an open reduction internal fixation surgery for the distal radius fracture with the screwdriver shaft, sleeve and drill bit.Implant insertion was completed without any problem during surgery, and a metal fragment was found near the inserted screw insertion site during cleaning before wound closure and it was removed.It may be a fragment of the drill bit, sleeve or screwdriver shaft.The surgery was completed successfully without any surgical delay.No further information is available.Two small metal chips together with the involved three instruments (03.226.004 screwdriver shaft cannulated, 03.226.016 compression sleeve, 310.221 drill bit) were returned to depuy synthes zuchwil for evaluation.Depuy synths conducted visual inspection of the returned devices.Both fragments were visually checked under the microscope and it was confirmed that both sides of the fragments are blackened ¿ the original color could not be determined.The returned instruments were received with signs of use but with no apparent damage.The drill bits are quite blunt.The returned instruments do not show any damage and the complaint is not related to the dimensions of the instruments.Therefore, no dimensional inspection is needed.A manufacturing record evaluation was performed for the finished device lot numbers, and no non-conformances were identified.No conclusion could be reached as on what caused the formation of the metal chips.The microscopic examination did not allow for any conclusions to be drawn about the origin of these fragments.Since all involved instruments are made from hardened stainless steel it is most likely that the chip originated from the screw.As part of depuy synthes quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: part: 03.226.016.Lot: 9004844.Manufacturing site: bettlach.Release to warehouse date: sept 9, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.Corrected data: d9, h3, h6.

• Brand Name: COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11399170
• Report Number: 8030965-2021-01521
• Device Sequence Number: 14585746
• Product Code: FZX
• UDI-Device Identifier: 07611819991668
• UDI-Public: (01)07611819991668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 03.226.016
• Device Lot Number: 9004844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/01/2021
• 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: DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE.; SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING.; UNK - SCREWS: TRAUMA.