MAUDE Adverse Event Report: SYNTHES GMBH TROCAR FOR MATRIXRIB SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.501.703
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was not received for investigation.A photo investigation was performed the image was reviewed and the complaint condition can be confirmed.There is a small deformation evident on the shaft of the part.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part number: 03.501.703.Lot number: t188197.Manufacturing site: (b)(4).Release to warehouse date: 19-dec-2019.A review of the device history records 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that the three instruments were discovered to have small holes and markings on the handles.No surgical or patient involvement.This report is for (1) trocar for matrixrib system.This is report 1 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.H3, h6: visual inspection: the trocar for matrixrib system (p/n: 03.501.703, lot #: t188197, qty: 1) was received at us customer quality (cq).Upon visual inspection of the complaint device, it showed small pitting marks on the device surface.No other issues were observed with the returned device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed trocar matrix rib: current and manufactured revisions no design discrepancy or defects were found.Dimensional inspection: feature: outer diameter of shaft measured dimension: conforming.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Comments.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: TROCAR FOR MATRIXRIB SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12273553
• Report Number: 8030965-2021-06395
• Device Sequence Number: 12036375
• Product Code: LXH
• UDI-Device Identifier: 07611819649309
• UDI-Public: (01)07611819649309
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2021

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: 03.501.703
• Device Lot Number: T188197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 08/18/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/09/2021; 09/09/2021
• 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: TROCAR FOR MATRIXRIB SYSTEM; TROCAR FOR MATRIXRIB SYSTEM; TROCAR FOR MATRIXRIB SYSTEM; TROCAR FOR MATRIXRIB SYSTEM