MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA-LCP OLECR PL 2.7/3.5 R 2HO L90 SST; PLATE,FIXATION,BONE

Catalog Number 02.107.202

Device Problems Failure To Adhere Or Bond (1031); Fitting Problem (2183)

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

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

Patient¿s weight is unknown.Additional device product code: hwc.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a right ulna open reduction and internal fixation (orif) on (b)(6) 2017, surgeon tried to insert the screws but realized that the 2 locking screws are spinning and are not locked.He decided to change to another plate, and mentioned that the plate is faulty.There was an unspecified time delay to procedure.There was no adverse event to patient.Concomitant device reported: locking screws (part # unknown, lo t# unknown, quantity 2).This report is for one (1) 2.7 mm/3.5 mm va-lcp olecranon pl 4h/lt/116 mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.Corrected data: (part number, lot number, and udi).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

Device history records review was completed for part# 02.107.202, lot# h288265.Manufacturing location: (b)(4) synthes, manufacturing date: feb 07, 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm va-lcp olecranon plate 2h/rt/90mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release 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 nonconformance 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.Product development investigation was completed.The returned 2.7mm / 3.5mm variable angle (va) locking compression plate (lcp) for olecranon is an implant available in the 2.7mm / 3.5mm va lcp elbow system for complex fractures involving the trochlear notch of ulna and coronoid.Visual inspection of the returned plate at customer quality (cq) revealed post manufacturing thread damage to several va holes.One section of the thread form on one va locking hole is broken and bent outward.Based on the pattern of the thread damage, it is most likely that a variable angle screw was attempted insertion without using the variable angle drill guide.As a result, the screw was over-angulated in excess of the 30 degree cone window which led to the screw not locking and damaging the plate thread.The two most proximal va holes show malformed thread (material edges hove rolled over).The reported complaint condition was not able to be replicated at cq via functional test because the screws were not returned.However, this complaint is confirmed due to the post manufacturing damage to the plate thread.The material was determined to be conforming at the time of manufacture based on review of the dhr.A dimensional inspection of features relevant to this complaint could not be obtained at cq due to the post manufacturing thread damage.Relevant drawing for the family of 2.7mm / 3.5mm variable angle (va) locking compression plates (lcp) for olecranon was reviewed during this investigation.No product design issues or discrepancies were observed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: VA-LCP OLECR PL 2.7/3.5 R 2HO L90 SST
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7163751
• MDR Text Key: 97064399
• Report Number: 8030965-2018-50059
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504479
• UDI-Public: (01)07611819504479(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.107.202
• Device Lot Number: H288265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR