MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/8H/LEFT/161MM; PLATE, FIXATION, BONE

Catalog Number 04.112.519

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported a locking compression plate (lcp) and screw were implanted on (b)(6) 2012.During the removal of the equipment, on (b)(6) 2015, the surgeon encountered difficulties because one of the screws is welded to the plate.The broken screw from going on the slopes of fibula and cannot be removed.This is report 2 of 2 for com-(b)(4).

Manufacturer Narrative

Implanted date: (b)(6) 2012, day unknown.(b)(6).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.

Manufacturer Narrative

A manufacturing investigation was preformed ¿ the implant was received in one piece and damaged at shaft hole m with additional marks and scratches on the surface finish near the location of the damage.The parts were received in sealed packaging.Features at the location of the damage were unobtainable.All other relevant dimensional features were measured and passed per the corresponding inspection sheet.Repeat features were measured at the iteration most near the break location.The parts were evaluated with the current gage to the current inspection requirements and were found to be conforming.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.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing date: august 28, 2013 ¿ manufacturing location: (b)(4).A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of 3.5mm ti low bend medial distal tibia plates was processed through the normal manufacturing and inspection operations with no rework or non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device is 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: 3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/8H/LEFT/161MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4740347
• MDR Text Key: 5886982
• Report Number: 2520274-2015-13531
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK013248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.112.519
• Device Lot Number: 7465294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1