MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5 TI VA-LCP POSTLAT DHP-LAT SUPT 4H/LT/88MM-MED-STER; PLATE, FIXATION, BONE

Catalog Number 04.117.104S

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.It is unknown when metal fragments were generated.Additional procode: hwc.It is unknown if or when device was explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Part: 04.117.104s; lot: l814662; manufacturing location: (b)(4); release to warehouse date: march 23, 2018; expiry date: march 01, 2028; no nonconformance reports (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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 the open reduction internal fixation (orif) was applied to distal humeral fractures on (b)(6) 2018.String-like metal fragments were found when screws were fixed to plates as follows: five screws = 2x va locking screws; 3x va locking screws.Two plates = 1x va-lcp dhp plate, posterolateral: one screw was inserted; 1x va-lcp dhp plate, medial: four screws were inserted.It is unknown which screws were fixed to which plates.It is unknown from where the fragments came.The fragments were removed.The screw was variable angle inserted, and the drill sleeve was secured to the plate.It was confirmed by x-rays that directions of the screw insertions and drill holes matched.Surgery was completed without further incident.There was no adverse consequence to the patient.This report is for a 2.7/3.5 ti va-lcp postlat dhp-lat supt 4h/lt/88mm-med-ster.This is report 4 of 7 for (b)(4).

• Brand Name: 2.7/3.5 TI VA-LCP POSTLAT DHP-LAT SUPT 4H/LT/88MM-MED-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7601051
• MDR Text Key: 111207393
• Report Number: 8030965-2018-54330
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819586413
• UDI-Public: (01)07611819586413
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120717
• 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: 05/21/2018

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: 04.117.104S
• Device Lot Number: L814662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/14/2018
• Date Device Manufactured: 03/23/2018
• 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