MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE; PLATE,FIXATION,BONE

Catalog Number 04.211.201S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional product code hwc reporter is jnj representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent the osteotomy surgery for hallux valgus (right).During the surgery, the plate got broken after the plate was bent or stretched a couple of times.Also, the hole of the plate for va locking screw had been broken.The surgery was successfully completed with a less-than-30-minute delay.The patient condition was stable.Concomitant device reported: unknown va holding pin (part#: unknown, lot#: unknown, quantity: 1).This complaint involves one (1) device.This report is for (1) 2.4/2.7mm ti va lckng x-plate extra small-sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the inspection has shown that the outer piece of one va (variable angle) hole is broken off, the fragment was returned for evaluation.At the fragment and in the area of the breakage are deep impression marks of an instrument visible.The on the first view intact va hole next to the broken one is deformed, it is unlikely that screw locking would have been possible in this hole.Here are also strong impression marks visible in general is the plate in a very used condition with scratches and impression marks all over.The anodized layer is worn away at all damages which indicates that they were caused post-manufacturing.The complaint is rated as confirmed as the plate is broken as complained.During the performed evaluation no manufacturing related issue could be detected.There are deep impression marks visible in the area of the breakage, these marks indicate that excessive force was applied and the either an incorrect instruments was used or that the instrument was not correctly attached to the va hole.Because the flat surfaces of the bending pliers part 03.211.005 are designed to protect the hole and would not leave such strong marks at the surface.The mentioned back and forth bending, which should be avoided according to the surgical technique, may also have played a certain role.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot =part: 04.211.201s, lot: 36p2914 , manufacturing site: (b)(4), release to warehouse date: 15.January 2020, expire date: 01.January 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10636101
• MDR Text Key: 210048963
• Report Number: 8030965-2020-07743
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819445123
• UDI-Public: (01)07611819445123
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.201S
• Device Lot Number: 36P2914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 11/06/2020
• Patient Sequence Number: 1
• Treatment: UNK - VA HOLDING PIN; UNK - VA HOLDING PIN