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

Catalog Number 03.010.440

Device Problem Separation Failure (2547)

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

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth/age, gender, and weight are unknown.Device is an instrument and is not implanted or explanted.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is currently pending completion.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon had to use great force to separate the connecting screw from the insertion handle during a procedure on (b)(6) 2016.In order to successfully separate the devices, the surgeon used hammer blows under insertion.The procedure was prolonged by approximately fifteen (15) minutes.It was noted that this issue was experienced by three (3) different physicians on three (3) separate occasions.Therefore, additional complaints have been created to address the other instances: (b)(4).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation and device history record review were performed for the subject device (insertion handle for suprapatellar, part number 03.010.440, lot number 15-9957).The subject device was returned and visually inspected.No damage to this device was observed.The subject device was returned with the complained cannulated connecting screw.The expert tibial nail associated with the complained event was not returned with the subject device.The returned cannulated connecting screw and insertion handle (subject device) of the expert tibial nail system were tested by assembling the insertion handle and an unused expert tibia nail (part number 04.004.440sab) with the connecting screw.No malfunction was detected during the assembly and disassembly.The problem reported in the complaint could therefore not be replicated.No design related root cause has been identified on the returned device.The non-manufacturing product development evaluation is closed as inconclusive.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.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5537659
• MDR Text Key: 41547013
• Report Number: 3000270450-2016-10078
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• 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: 15-9957
• Other Device ID Number: (01)07611819447936(10)15-9957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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