MAUDE Adverse Event Report: SYNTHES TUTTLINGEN SCREW AND PLATE HOLDING FORCEPS

Catalog Number	347.985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.A review of the service history records has been requested.Manufacture date is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
It was reported that two instruments were discovered damaged in sterile processing.The tip is broken off on one side of the screw forceps and the tip is bent on the 4 mm hex screwdriver.There was no patient involvement.This is report 2 of 2 for com-(b)(4).
Additional Manufacturer Narrative
No service history review can be performed as part number 347.985 with lot number(s) t133205 is a lot/batch controlled item.The manufacture date of this item is unknown.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Please launch a device history record review (dhr).There were two manufacturing dates for this lot.Manufacturing date: 04-aug-2016.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 (b)(4) parts of the lot were checked 100% for critical features and for function at the final inspection on 29-jul-2016.Manufacturing date: 14-sep-2016.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 (b)(4) parts of the lot were checked 100% for critical features and for function at the final inspection on 25-aug-2016.(b)(4) was started during manufacturing for welding seams with pores.(b)(4) parts were reworked, 100% inspected and were found to be conforming.Therefore the nc has no relevance to the complaint 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.
Additional Manufacturer Narrative
Service and repair evaluation was completed.The customer reported the tip was broken off of one side of the instrument.The repair technician reported the tip was broken off.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.Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review, service and repair history review, and drawing review were performed as part of this investigation.This complaint is confirmed, as the hexagonal screwdriver is warped and the tip is no longer on the screw and plate holding forceps.The instrument is used in multiple procedures to remove 7.3mm cannulated screws; it is unclear from the complaint description which procedure the device was used in.Based on the received photograph, the distal tip of the forceps is broken off, and no longer contains the hook.The overall condition of the device is good, with minimal signs of wear to the device.Relevant 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.Although details on the use of the devices are unknown, the multiuse devices are put under constant stress to perform their intended functions.The most likely root cause of the complaint conditions is repetitive use and reprocessing over the products¿ lifetime.No new, unique or different patient harms were identified as a result of this evaluation.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: SCREW AND PLATE HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6525610
• Report Number: 9680938-2017-10070
• Device Sequence Number: 1268720
• Product Code: HTD
• UDI-Device Identifier: 10886982193629
• UDI-Public: (01)10886982193629(10)T133205
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/05/2017

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: 347.985
• Device Lot Number: T133205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/24/2017; 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1