MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 36MM; PIN, FIXATION, SMOOTH

Catalog Number 459.360VS

Device Problems Difficult to Insert (1316); Naturally Worn (2988)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing location: (b)(4).Manufacturing date: february 02, 2016.Expiry date: january 01, 2026.No non-conformance reports were generated during production.There were no issues during the manufacture of the product that would contribute to this complaint condition.No deviations were noted.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported during the surgery for intertrochanteric femoral fracture, the drill bit interfered to the nail while drilling the hole; however, the drill bit went through.The surgeon then tried to insert the locking bolt; however, the locking bolt interfered with the nail.The head of the bolt seemed almost worn out and the bolt started idling during the insertion, the surgeon gave up inserting the locking bolt.There was a twenty (20) minutes surgical delay.No adverse consequence was reported.Concomitant devices: pfna (part 472.100s, lot 9806800 quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the complained problem could not be reproduced; there is no evidence suggesting why the locking bolt interfered with the nail.The device history record review confirmed that this device was manufactured according to specifications.This lot was released after final inspection with no findings.The conducted visual inspection showed a completely damaged head, which likely came from the removal procedure.Also, the tip of the locking bolt is badly damaged.The visible signs clearly indicate that strong contact with the nail occurred.The locking bolt became stuck in the nail during insertion.No product fault could be identified.An exact root cause could not be determined for this complaint; therefore, the event is classified as unconfirmed.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 36MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5729417
• MDR Text Key: 47533551
• Report Number: 3009417901-2016-10017
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.360VS
• Device Lot Number: 5937617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1