MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LOCKING PLIERS; PLIERS,SURGICAL

Catalog Number 359.204

Device Problems Break (1069); Material Fragmentation (1261); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A service history record review will be requested.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 that the set of locking pliers will not lock.It was further explained that a piece of the instrument was broken off.The reported issues were discovered during routine inspection.It is unknown when the instrument became damaged.There was no report patient or surgical procedure associated with the reported conditions.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 359.204 with lot number(s) t941512 is a lot/batch controlled item.The manufacture date of this item is december 29, 2009.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Manufacturing date: december 22, 2009.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 parts of the lot were checked 100% for important features and for function at the final inspection.No non-conformance reports were generated during production.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.

Manufacturer Narrative

Device returned may 11, 2017.The customer reported the device would not lock, and a piece broke off.The repair technician reported the screw that held the pivot lock on broke off.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was forwarded to customer quality.The evaluation was confirmed.The locking plier (359.204, lot t941512, mfg 22-dec-2009) was evaluated by customer quality and the complaint condition was able to be confirmed.As depicted in photographs of the device, the device was returned in fairly worn condition with numerous nicks and witness marks evident throughout the device but the damage was consistent with 7+ years of use.The weld that holds m3x13mm cylindrical set screw (also referred to as the pivot lock) to the upper plier was broken, allowing the set screw to disengage from the handle.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Replication of the complaint is not applicable as the device was received broken.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were identified during the investigation.The 359.204 locking pliers are found within the titanium/stainless steel elastic nail system and the cannulated pediatric osteotomy system (capos) to be used with the titanium/stainless steel elastic nails.They are used in the removal of the elastic nail implants.They are intended to grip the elastic nail securely while the user applies forces in an effort to remove the implant.The elastic nails come in a variety of diameter sizes, ranging from 2.0mm to 4.0mm.The pliers have a locking ratchet system, which allows the user to secure and lock the pliers around the nail, while the implant is being removed.No service history review can be performed as part number 359.204 with lot number(s) t941512 is a lot/batch controlled item.The manufacture date of this item is 29-dec-2009.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Product drawings were reviewed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.A device history review was performed for the returned instruments¿ lot numbers and in each instance no mrrs, ncrs or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.Change order dated 05-may-2014 modified the drawing to meet internal design changes by (b)(4).The function of upper pliers was not impacted by the changes identified in the change order.Per the drawings, the m3x13mm cylindrical set screw is plug welded with 440b stainless steel material.Although a definitive root cause could not be determined, cyclic loading by the catch/lever over the 7+ year lifespan of the device could have contributed to complaint condition of broken set screw.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: LOCKING PLIERS
• Type of Device: PLIERS,SURGICAL
• 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: 6445558
• MDR Text Key: 71236099
• Report Number: 9680938-2017-10057
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982197054
• UDI-Public: (01)10886982197054(10)T941512
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 359.204
• Device Lot Number: T941512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2009
• 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