MAUDE Adverse Event Report: SYNTHES SALZBURG HOLDING FORCEPS

Model Number	351.782
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Information on if patient was involved is unknown, for now - no patient involvement until further notice.Unknown.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Patient code (b)(4) used for: it is unknown if there was any patient involvement.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was requested.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
It was reported that holding forceps are broken.It is unknown if there was any patient involvement.There is no further information available.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 351.782, lot# 5017490.Manufacturing location: (b)(6), manufacturing date: jan 18, 2008.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Patient id was initially reported as ni in error.It is unknown if the patient was involved.No patient information available for reporting.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
Customer quality (cq) engineering investigation: this complaint is confirmed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.Visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection: one of the jaw of the returned holing forceps (p/n 351.782, lot# 5017490) was broken at the starting point of the feature and the broken fragment was not returned with the complaint.Some normal amount of wear and dentures were observed on the intact jaw; the wear is in line with general usage of the device.The overall balance of the device looks in a good condition with some superficial wear of the rest of the device surface which does not impact functionality.No new malfunctions were identified as a result of the investigation.Dhr review: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Drawing review: drawings were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.A dimensional inspection of features relevant to this complaint could not be obtained at cq due to the condition of the returned device (broken un-returned jaw feature with distorted edge break).No definitive root cause could be determined.The reusable device is approx 9 years old.It is possible that rough handling during operation and/or sterilization process, application of excessive/off-axis force during operation may have caused the issue.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: HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• MDR Report Key: 6940887
• Report Number: 8030965-2017-15409
• Device Sequence Number: 13705831
• Product Code: HTD
• UDI-Device Identifier: 10886982193995
• UDI-Public: (01)10886982193995(10)5017490
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2017

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 Model Number: 351.782
• Device Catalogue Number: 351.782
• Device Lot Number: 5017490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/12/2017; 11/10/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/07/2017; 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1