MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. MAT LOCK L-PLATE W/POSITIONING HOLE SHOR; PLATE, FIXATION, BONE

Catalog Number 04.511.901S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 that on (b)(6) 2021, during a maxillary lefort 1 procedure two straight plates could not be locked because the screws idled.The procedure was completed by replacing the plates which resulted in 30-minute surgical delay.The patient was reported as stable after the procedure.This report involves one (1) mat lock l-plate w/positioning hole shor.This is report 2 of 3 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- visual analysis of the returned sample revealed that one of the locking hole for mat lock l-plate w/positioning hole shor was damaged.This could have caused the complaint condition.Additionally, scratches and discoloration marks were visible on the plate.This could have happen due to the application of excessive force during bending the plate.No other issues were identified.The dimensional inspection was not performed as it's not pertaining to the alleged complaint condition.The encoded complaint condition of unable to assemble cannot be confirmed since the mating part was not returned for evaluation.Thus functionality test on the device cannot be performed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for mat lock l-plate w/positioning hole shor.While no definitive root cause could be determined, there is a possibility that plate could have got damaged during application of unintended forces while bending the plate.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code: 04.511.901s, lot number: 1l32226, manufactured date :13 sep 2018.A manufacturing record evaluation was performed 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: MAT LOCK L-PLATE W/POSITIONING HOLE SHOR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12805065
• MDR Text Key: 283247643
• Report Number: 8030965-2021-09484
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819385498
• UDI-Public: (01)07611819385498
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.901S
• Device Lot Number: 1L32226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAT LOCK L-PLATE W/POSITIONING HOLE SHOR; UNK - SCREWS: CMF