MAUDE Adverse Event Report: SYNTHES GMBH TI VA-LCP VOLAR DISTAL RADIUS PLATE 4H HEAD/3H SHAFT/RT; PLATE, FIXATION, BONE

Catalog Number 04.110.205

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.A device history record (dhr) review was conducted: part number: 04.110.205, lot number: 5814359, part manufacture date: 18-jul-2008, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti va-lcp volar distal radius plate 4h head/3h shaft/rt 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.Review of the raw material is required only for broken devices.This complaint was not initiated for a broken plate.Therefore, no raw material review was conducted for this dhr review.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reports an event in (b)(6) as follows: it was reported on (b)(6) 2014, after analyzing the label and length of the variable angle locking compression plate (lcp) distal radius plate, it was found out that there was a mismatch.In an electonic catalog, the plate length was given 45mm.In an official document, the va-lcp distal radius plates for fragment-specific fracture fixation with variable angle locking technology, the length for the same article was 47mm.When the plate was measured, it clearly appeared that the plate length was more than 45mm.There was no procedure nor patient involvement.This report is for one (1) ti va-lcp volar distal radius plate 4h head/3h shaft/rt.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI VA-LCP VOLAR DISTAL RADIUS PLATE 4H HEAD/3H SHAFT/RT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11983349
• MDR Text Key: 255777549
• Report Number: 8030965-2021-04817
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819980143
• UDI-Public: (01)07611819980143
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K071184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.110.205
• Device Lot Number: 5814359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1