MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Catalog Number 399.99

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.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 review has been requested.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 Description

(b)(6) reported that upon inspection it was noticed that the reduction forceps with serrated jaw was not racheting.There are 2 devices in this complaint.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.No service history review can be performed as part number 399.99 with lot number(s) t957301 is a lot/batch controlled item.The manufacture date of this item is 25-jan-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A device history record (dhr) review was performed on part# 399.99 lot# t957301: manufacturing date: 21-jan-2011.Review of the device history record of tuttlingen 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 31 parts of the lot were checked 100% for important features and for function at the final inspection on 19-jan-2011.No non conformance reports (ncrs) were generated during production.A product investigation was performed on the returned device.Two (2) 399.99 reduction forceps with lot numbers t957301 and t924810 were returned and reported to no longer ratchet.This complaint condition was likely caused by over six 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, device history review (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 399.99 reduction forceps are instruments routinely used in the small fragment locking compression plate (lcp) system per relevant technique guide.The device was returned and reported to no longer ratchet.This condition is confirmed; the device does ratchet to a limited extent but the mechanism is loose and not consistent on either device.It is likely that over six years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.Lot t957301 was manufactured in 1/2011 and is over six years old.Lot t924810 was manufactured in 7/2008 and is over eight years old.The balance of the returned devices is in otherwise fairly good condition with only some superficial wear.Relevant 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.The complaint condition for this device can be replicated.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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

This report is 1 of 2 for com-(b)(4).

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6412019
• MDR Text Key: 70185240
• Report Number: 9680938-2017-10044
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175(10)T957301
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.99
• Device Lot Number: T957301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2011
• 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