MAUDE Adverse Event Report: SYNTHES TUTTLINGEN UNIVERSAL BENDING PLIERS; N/A

Catalog Number 391.963

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Device history record review for part # 391.963, lot # t110339: manufacturing date: 20-feb-2015.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 48 parts of the lot were checked 100% for ctq features and for function at the final inspection on (b)(4) 2015.No non conformance reports (ncrs) were generated during production.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 Description

It was reported by service and repair that evaluation equipment universal bending pliers was found broken during inspection activities of the set.No issues were reported by the customer.No patient involvement or surgical delay reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No additional information has been received for these fields.(b)(4).A product development investigation was performed for the universal bending pliers(part number 391.963, lot number t110339).The subject device was returned with the complaint condition stating the bending pliers were received in two pieces at customer quality (cq).The upper handle has sheared off flush with the intersection of the bottom handle.Whether this complaint can be replicated is not applicable as the bending pliers are already broke.This complaint is confirmed.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.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 48 parts of the lot were checked 100% for ctq features and for function at the final inspection on 20-feb-2015.No non-conformance records (ncrs) were generated during production.Relevant drawing for the returned instrument was reviewed: the design, materials and finishing processes were found to be appropriate for the intended use of these devices.No new, unique or different patient harms were identified as a result of this evaluation.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No definitive root cause was able to be determined however the failure mode is consistent with the application of excessive force.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL BENDING PLIERS
• Type of Device: N/A
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6069608
• MDR Text Key: 58849232
• Report Number: 9680938-2016-10165
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.963
• Device Lot Number: T110339
• Other Device ID Number: (01)10886982198549(10)T110339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1