MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM CANNULATED SCREW SHORT THREAD/38MM; SCREW, FIXATION, BONE

Model Number	207.638
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device broke during insertion; device not considered implanted/explanted complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 is not distributed in the united states, but is similar to device marketed in the usa.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 synthes reports an event in (b)(6) as follows: it was reported intraoperatively on (b)(6) 2022 metal debris was noted in the patella from a cannulated screw short thread in an open patella fracture procedure.First screw passed no problem.1.25mm wire passed.2.7mm drill past near fracture but not into the far fragment.Not tapped.4mm screw passed but as advanced under xr was evident that there was metal debris, so when screw taken back it was found to be broke.Surgeon is unsure which screw broke.The procedure was completed successfully with a 30 minute surgical delay.Concomitant devices reported: unk - drill bits: trauma (part # unknown, lot # unknown, quantity # 1) ; unk - cable/wire (part # unknown, lot # unknown, quantity 1).This is report 1 of 2 for (b)(4).This report is for a cannulated screw short thread.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary: x-rays were provided and returned to depuy synthes for evaluation.Visual analysis of the provided x-rays revealed that there was no damage or defects with the cannscr ã¸4 self-drill l38/12 sst.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for cannscr ã¸4 self-drill l38/12 sst.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the product code: 207.638ts, lot number: 8l34258; and no non-conformances were identified.

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14398476
• Report Number: 8030965-2022-03193
• Device Sequence Number: 5527938
• Product Code: HWC
• UDI-Device Identifier: 10886982148230
• UDI-Public: (01)10886982148230
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Model Number: 207.638
• Device Catalogue Number: 207.638TS
• Device Lot Number: 8L34258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNSCR ø4 SELF-DRILL L42/14 SST; UNK - CABLE/WIRE; UNK - DRILL BITS: TRAUMA
• Patient Age: 17 YR
• Patient Sex: Unknown