MAUDE Adverse Event Report: SYNTHES SELZACH SLIDING MECHANISM; FORCEPS

Catalog Number 314.291

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A service and repair evaluation was performed for the returned subject device.The customer reported the plastic handle broke off in one piece.The repair technician reported the handle was broken.¿handle cracked/broken¿ is the repair category that this repair will be coded under.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The service and repair evaluation was confirmed.The subject device will be forwarded to synthes customer quality for additional investigation.A service and repair history record review was attempted for the subject device; however, the device is a lot/batch control item.The release to warehouse date is sep 21, 2011.The service history review is unconfirmed.Manufacturer: synthes (b)(4).Date of manufacture date: aug 11, 2011.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 patient underwent surgery for a fractured right hip on (b)(6) 2017.During the procedure, as the surgeon was using the sliding mechanism from the collinear reduction clamp set to reduce the fracture, about 3 inches of the black, plastic handle broke off as one piece.It was reported that it ¿snapped off" just under the four screws that hold it on to the metal piece.The four screws remained intact.It was reported that the clamp used for reduction remained in the patient and the surgeon set the handle aside and moved along with the surgery.It was reported that there was no patient consequence due to the breakage and no delay in surgery.The clamp was removed approximately 10 minutes later and the patient was implanted with a trochanteric femoral nail (tfn) nail, a lag screw and one distal locking screw.The remainder of the surgery was reported as successful and the patient stable.Concomitant medical products: clamp (part #unknown, lot #unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was performed.A visual inspection under 5x magnification, dimensional inspection of features related to this complaint, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.The handle has broken as reported.The break occurred at the inferior edge of the bottom screw of two screws that secure the handle to the device.The small superior portion of the handle still remains attached to the device but the large inferior handle portion is separate from the device.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The material at the fracture surface appears homogeneous when viewed under 5x magnification.The lateral wall thickness of the handle component at the location of breakage measured and found to be within specification per relevant handle component drawing.The posterior and anterior wall thickness of the handle component at the location of breakage was measured in several locations and found to be within specification as per handle component drawing.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The break occurred most likely due to application of excessive force on the nylon handle of this 5+ year old reusable instrument.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: SLIDING MECHANISM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6414425
• MDR Text Key: 70320919
• Report Number: 3000270450-2017-10091
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779(10)11-7600
• 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: 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: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.291
• Device Lot Number: 11-7600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2011
• 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
• Treatment: UNKNOWN CLAMP, QUANTITY 1