MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.221.011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2020, the cerclage passer was not working.The two arms of the instrument were not in alignment with each other.The procedure was completed using another device.There was no surgical delay.The procedure and patient outcome are unknown.There is no further information available.This report is for one (1) cerclage passer, dividable forceps, large.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.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
Concomitant device reported: unk - cable/wire (part# unknown; lot# unknown; quantity: unknown).
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.H6: part: 03.221.011, lot: l864531, manufacturing site: umkirch, release to warehouse date: 18.July 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Complaint is confirmed as we are able to confirm complaint description (deformed/bent) based on the received pictures.Product was not returned therefore no further investigation possible.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 (information or/and material), 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.
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.Visual inspection: the cercl-passer ø60 min-invasive (part #: 03.221.011, lot #: l864531) was received at us cq.Visual inspection of the complaint device showed that the open tips of both prongs which allow the cable to pass through were deformed.Both tips did not align when in closed position.Functional test: a functional assessment was not performed with the complaint device since the cable was not returned and also due to the damage of the device.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the cercl-passer ø60 min-invasive (part #: 03.221.011, lot #: l864531) as the open tips of both prongs which allow the cable to pass through were deformed hence causing the misalignment and the assembling issues reported.A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 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: CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10608444
• Report Number: 8030965-2020-07554
• Device Sequence Number: 1178276
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/07/2020

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: 03.221.011
• Device Lot Number: L864531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 11/03/2020; 11/11/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/02/2020; 11/18/2020; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2018
• 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: UNK - CABLE/WIRE
• Patient Sex: Unknown