MAUDE Adverse Event Report: SYNTHES SELZACH 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.452S

Device Problems Sticking (1597); Fitting Problem (2183)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient identifier is not available for reporting.The patient¿s exact weight is unknown; however, it was reported to be within ¿normal¿ range.(b)(4).The device has not been explanted.The complainant part is not expected to be returned for manufacturing review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history record review: manufacturing location: (b)(4) - manufacturing date: june 25, 2015 - expiry date: june 1, 2025.Please note, this dhr review is for sterilization procedure only: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A review of the non-sterile counterpart (04.004.452 / lot 9520712) was also completed with results as follows: manufacturing location: (b)(4) - manufacturing date: june 10, 2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 there was cold welding between the connecting screw and the expert tibia nail following insertion of the nail with a supra-patellar instrumentation set.The surgeon reportedly heard a creaking sound as the devices were being attached.The surgeon had to employ a screwdriver and a wrench in order to disconnect the connecting screw.It was only with this excessive force, and the use of the additional instrumentation, that the two (2) devices could be separated.The procedure was completed with a ten (10) minute surgical delay.The patient¿s post-operative status was noted to be ¿ok.¿ this report is 2 of 2 for (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE
• 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: 5416056
• MDR Text Key: 37720211
• Report Number: 3000270450-2016-10030
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.452S
• Device Lot Number: 9535588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16 YR