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

Catalog Number	03.501.703
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: without a lot number the device history records review could not be completed.Product was not returned.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 the three instruments were discovered to have small holes and markings on the handles.No surgical or patient involvement.This report is for one (1) trocar for matrixrib system.This is report 2 of 3 for (b)(4).

• Brand Name: TROCAR FOR MATRIXRIB SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): UMKIRK SYNTHES GMBH (DE); im kirchenhurstle 4-6; umkirch 79224 ; GM 79224
• MDR Report Key: 12273554
• Report Number: 3003862213-2021-00004
• Device Sequence Number: 14159469
• 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
• 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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 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.