MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MESH CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number	391.952
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).A service history evaluation/review was attempted.The investigation of the complaint articles has shown that: a (b)(4) service history review for part #391.952, lot #t976156 need to be completed.The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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
(b)(6) reported the following event: during an unknown surgery on (b)(6) 2017, a small piece of the end of the mesh cutter broke off.It was reported that the piece was retrieved and no fragments remain in the patient.There was no delay in surgery as the procedure was completed with a similar device.The patient was reported as stable and the surgery completed successfully.This complaint is for one device.Concomitant device: mesh (part #unknown, lot #unknown, quantity unknown).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
No service history review can be performed as part number 391.952 with lot number(s) t976156 is a lot/batch controlled item.The manufacture date of this item is may 31, 2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Manufacturing date: may 29, 2012.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All parts of the lot were checked 100% for important features and for function at the final inspection.No non-conformance reports were generated during production.A service and repair evaluation was completed: the customer reported the end of the mesh cutter broke off.The repair technician reported that one of the tips was broken off and missing, and the second tip was cracked and coming apart.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.A visual inspection at customer quality determined that one of the tips has broken off and is missing, and the second tip is cracked and is coming apart.The material surface at the location of breakage appears homogeneous when viewed under 5x magnification.Relevant drawings were reviewed.No product design issues or discrepancies were observed.Root cause could not be determined at customer quality.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No new malfunctions were identified as a result of the investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.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: MESH CUTTER
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6443271
• Report Number: 9680938-2017-10054
• Device Sequence Number: 681950
• Product Code: HTZ
• UDI-Device Identifier: 10887587041001
• UDI-Public: (01)10887587041001(10)T976156
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2017

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: 391.952
• Device Lot Number: T976156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/27/2017; 05/02/2017
• 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: MESH - PART #UNKNOWN, LOT #UNKNOWN, QUANTITY UNK