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

Catalog Number 03.010.440

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

There was reportedly no patient involvement.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that during an in-service training for residents at the hospital, using the suprapatellar set, it was noted that the insertion handle would not attach to the aiming arm for demonstration purposes.There were reportedly no problems with any of the other instruments in the set.The in-service training did not involve any patients.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Device history records review was completed for part# 03.010.440, lot# 160139-101.Manufacturing location: (b)(6), manufacturing date: (b)(6) 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed for part# 03.010.440, lot# 160139-101.A visual inspection, functional test, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The devices were each received intact.One of the two locating dowel pins on the aiming arm is bent outward preventing proper alignment/seating of the insertion handle.The returned insertion handle shows no damage or wear.This complaint is confirmed.The complaint condition was able to be replicated at customer quality.A review of the design drawings (current/manufactured revision) was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for their intended use when employed and maintained as recommended.Unable to determine a definitive root cause for the bent pin.The damage (bent pin) is most likely the result of rough handling during previous use or during sterile processing.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: INSERTION HANDLE FOR SUPRAPATELLAR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 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: 6174694
• MDR Text Key: 62538370
• Report Number: 2520274-2016-15680
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.010.440
• Device Lot Number: 160139-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1