MAUDE Adverse Event Report: SYNTHES TUTTLINGEN COMPRESSION FORCEPS; INSTRUMENT COMPRESSION

Catalog Number	03.211.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was conducted on part # 03.211.400, lot # t961302: manufacturing date: 27-jul-2011.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 important features and for function at the final inspection on 27-jul-2011.No non conformance reports (ncrs) were generated during production.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 by service and repair department that synthes evaluation equipment-the compression forceps has a broken leaf spring.The issue was identified during inspection activities of the evaluation set.There were no issues reported by the customer.This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device compression forceps, part number 03.211.400, lot number t961302).The subject device was returned with the complaint condition stating: the 03.211.400 lot number t961302 compression forceps was returned and reported to have a broken leaf spring.This complaint condition was likely caused by over five years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 03.211.400 compression forceps are instruments routinely used in the 2.7mm variable angle locking calcaneal plating system.The device was returned and reported to have a broken leaf spring.This condition is confirmed; a hairline crack extends transversely through the leaf spring where the set screw connects it to the forceps handle.It is likely that over five years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 7/2011 and is over five years old.The balance of the returned device is in good functional condition with minimal visible wear.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.All measurements have been performed by calipers.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6393107
• Report Number: 9680938-2017-10038
• Device Sequence Number: 500366
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267(10)T961302
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2017

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: 03.211.400
• Device Lot Number: T961302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1