MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Catalog Number 03.010.440

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.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.The subject device has been received.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.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 a driving cap/threaded and an insertion handle for suprapatellar could not be disassembled from each other after surgery.The scrub technician attempted to disassemble the devices using a wrench.During the attempt, the threaded portion of the driving cap broke off inside the insertion handle.No patient involvement.This is report number 2 of 2 for complaint (b)(4).

Manufacturer Narrative

An investigation summary was performed.Our investigation of the complaint articles has shown that: one driving cap (part # 03.010.523, lot # 8953354) was returned for investigation.The driving cap shows regular use, with hammer marks and gouges on the head of the device consistent with high impact force.The distal threaded tip of the of the driving cap is broken off and was returned stuck in the returned insertion handle (part # 03.010.440, lot # 14-6678).Although the exact cause for the complaint condition could not be determined, the damage appears to be the result of hammering on the device after it was cross threaded or before it was fully seated against the insertion handle and thus deforming the threads.Subsequently, the force necessary to dislodge the weakened driving cap caused the tip to break.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint condition is confirmed.Device 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: INSERTION HANDLE FOR SUPRAPATELLAR
• Type of Device: NAIL,FIXATION,BONE
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6082770
• MDR Text Key: 59295323
• Report Number: 3000270450-2016-10266
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111667
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.440
• Device Lot Number: 14-6678
• Other Device ID Number: (01)10886982068828(10)14-6678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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