MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH VA-LCP PROX OLECR PL 2.7/3.5 R 2HO L73 T; PLATE, FIXATION, BONE

Catalog Number 04.107.002S

Device Problem Material Fragmentation (1261)

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

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information available for reporting.It is unknown if the devices were fully implanted or explanted.Devices are not available for return.Device history review part# 04.107.002s lot# h347763, part mfg date: 31 may 2017, mfg location: (b)(4), part expiration date: 01 may 2027, dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm ti va-lcp proximal olecranon 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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)(4) as follows: it was reported during a ulnar proximal fracture repair on (b)(4) 2018, fragments were generated from two screws and or the plate during tightening.The surgeon was utilizing a torque limiter with handle to implant an olecranon construct which was to include six (6) screws and an olecranon plate.Since it was too tight to fix those screws, the handle was changed to another handle.Although four (4) screws were properly tightened, the surgeon had to stop fixing the remaining two screws because metal fragments came out of either the screw heads or the plate.It is unknown if all fragments were removed.The surgery was delayed by five minutes.Patient status is unknown.Concomitant devices: torque limiter (part# 03.110.002, lot# unknown, qty 1).Handle (part# 03.110.005, lot# unknown, qty 1).Handle (part# 311.431, lot# unknown, qty 1).Screws (it is unknown which screws were impacted; possible concomitant screw are listed below).Part #04.211.042s ; lot #l534306.Part #04.211.014s ; lot #l623771.Part #04.211.012s ; lot #l589686.Part #04.211.040s ; lot #l476897.Part #04.211.010s ; lot #l603719.Part #04.211.026s ; lot #l488624.This is report 2 of 2 for (b)(4).

• Brand Name: VA-LCP PROX OLECR PL 2.7/3.5 R 2HO L73 T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7259405
• MDR Text Key: 100060283
• Report Number: 8030965-2018-50990
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504776
• UDI-Public: (01)07611819504776(17)270501(10)H347763
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.107.002S
• Device Lot Number: H347763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/09/2018
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1