MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 38MM; PIN, FIXATION, SMOOTH

Catalog Number 459.380VS

Device Problem Unintended Movement (3026)

Patient Problem Sedation (2368)

Event Date 06/02/2015

Event Type  Injury  

Manufacturer Narrative

Additional narrative: device history records was conducted.The report indicates that, manufacturing site: (b)(4), manufacturing date: 26.Jun.2014, expiry date: 01.Jun.2024, the 459.380vs - 5929547, 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 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on (b)(6) 2015.During the operation, the surgeon decided to ream the femur head for blade insertion as the patient¿s bone quality was good.During the reaming, however, the reamer interfered with the nail.The surgeon wound up inserting a proximal femoral nail antirotation (pfna) blade instead and completed the procedure.A thirty (30) minute surgical delay was noted.Postoperative x-rays confirmed that the blade was not properly inserted into the blade hole.A same-day reoperation was performed.This report is 2 of 5 for (b)(4).

Manufacturer Narrative

Patient identifier and weight are unknown.Device was not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Manufacturer Narrative

Product investigation summary: - involved / received parts: (1) x 459.380vs / lot 5929547: the returned part shows visual signs of wear and tear.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately, the exact cause of this occurrence could not be determined as no detailed clinical information was provided and not all involved parts were available.The device passed all the functional requirements successfully.Based on the manufacturing investigation results and without all involved parts, it was concluded that the cause of failure was not due to any manufacturing non-conformances no product fault could be detected 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: 4.9MM TI LOCKING BOLT 38MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg PA 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4846863
• MDR Text Key: 13956512
• Report Number: 2520274-2015-14482
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.380VS
• Device Lot Number: 5929547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR