MAUDE Adverse Event Report: SYNTHES GMBH 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/254MM LENGTH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.605.520
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a spinal arthrodesis, the laminectomy punch was not arranged correctly.The procedure was successfully completed.The patient outcome was reported as good.This report is for one (1) 40 deg up-biting laminectomy punch 4mm width/254mm length.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Reporter is a j&j employee.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.Investigation summary.Visual inspection: the laminectomy punch, 40° up-biting, 254mm length 4mm width (p/n: 03.605.520, lot #:t196692) was received at us cq.The device was received in multiple pieces, but all pieces were returned.The end threads of the pivot pin appeared damaged, but it is possible this was caused by the peening procedure called out by note 14 of drawing 03_605_520 rev.E.No other defects were noted with the device.Device failure/defect identified? yes.Functional assessment: since the device was received with the permanently set pivot pin removed, it can not be reassembled to specification.Therefore a functional assessment was not performed.Dimensional inspection: a dimensional inspection was not performed due to device geometry.Document/specification review: no design or manufacturing discrepancies were noted.Complaint confirmed? yes.Conclusion: note 14 of drawing 03_605_520 rev.E specifies that the "pivot pin to be permanently set, peened and ground flush on both sides." since the device was received with the permanently set pivot pin removed, it can not be reassembled to specification.Therefore it can be determined that the device is broken, and the complaint condition is confirmed.A definitive assignable root cause cannot be determined from the provided information.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 lot: part number: 03.605.520, lot number: t196692, manufacturing site: (b)(4), release to warehouse date: 12-mar-2020.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.

• Brand Name: 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/254MM LENGTH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12819798
• Report Number: 8030965-2021-09530
• Device Sequence Number: 5760799
• Product Code: LXH
• UDI-Device Identifier: 07611819317703
• UDI-Public: (01)07611819317703
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 03.605.520
• Device Lot Number: T196692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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
• Patient Sex: Unknown