MAUDE Adverse Event Report: SYNTHES GMBH 7.0MM REDUCTION HEAD-ANGLED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	352.055
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H6: 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 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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent an orif surgery for a left femoral subtrochanteric fracture.During the surgery, the flexshaft (352.040), head (352.055), and handle (351.150) were assembled and used as a reducer.At that time, the surgeon inserted the reducer without a reaming rod.The surgeon did not notice it and kept proceeding with the procedure, as a result, the head came off and remained in the proximal part of the fracture.The removal of the head was done via the wound that had been prepared for a fixation.Therefore, there was no additional creation of a wound for the removal.The surgery was completed successfully, and the surgical time was extended approximately 7 minutes due to the removal of the head.No further information is available.This report is for a 7.0mm reduction head-angled.This is report 1 of 1 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found signs of lightly breakage at the reduc-head angl.The broken fragment it is still attached to the device.Without an x-ray we cannot confirm that a fragment has remained inside the patient.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed since it was not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the reduc-head angl would contribute to the complained device issue.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.Drawing/specifications reviewed se_204631 rev.C current and manufactured.Dimensional inspection: n/a.H4, h6 product code: : 352.055, lot number : 2392210, release to warehouse date : 19.Aug.2008, expiration date : na, supplier: (b)(4), manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot 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.
Event or Problem Description
This is report 1 of 2 for (b)(4).

• Brand Name: 7.0MM REDUCTION HEAD-ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17810944
• Report Number: 8030965-2023-12083
• Device Sequence Number: 7183416
• Product Code: LXH
• UDI-Device Identifier: 10886982194169
• UDI-Public: (01)10886982194169
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 352.055
• Device Lot Number: 2392210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNREAM FLEXSHAFT; T-HANDLE W/QUICK-COUPL
• Patient Sex: Unknown