MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM LCP PLATE 8 HOLES/64MM-2.0MM THK; PLATE, FIXATION, BONE

Catalog Number VP4022.08

Device Problem Material Deformation (2976)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: veterinary case: it was reported that on (b)(6) 2022, the side of the plate in question did not appear to be polished and the surface was rough and uneven.There was no patient or procedure involvement.No further information is available.This report is for one (1) 2.4mm lcp plate 8 holes/64mm-2.0mm thk.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.510k#: device is a veterinary product.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6 h3, h6: the device has been 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 d9, h3.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d3, h3, h6 28-jul-2022 by: (b)(6) a dhr review was not performed for this pi.This part number is manufactured by elmira.Please reassign this task to the correct group.29 july 2022 by: (b)(6).Part number: vp4022.08.Lot number: 672p013.Part manufacturing date: 16 february 2022.Manufacturing site: elmira.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint-related anomalies.The device history record shows lot 672p013 of 2.4 mm lcp plates was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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.A review of the component device history record(s) determined the component lot 418p780 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 386p589 met all specifications with no issues documented that would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to jabil where a visual inspection of the returned device was conducted.As received condition of device: the returned device was received loose in a bag and laser etched part number plate, batch.A visual inspection of the 2.4mm lcp plate 8 holes/64mm-2.0mm thk shows the plate appears to be in the same acceptable conforming condition cosmetically per inspection sheet and top-level drawing as it was when it shipped from the jabil elmira manufacturing facility.Per inspection sheet used for final inspection of the plate, a 100% cosmetic inspection was performed at normal reading distance per t-g-b331, understanding and using visual standards, on batch 672p013 prior to release of product to the warehouse.During the evaluation of the plate involved in this complaint, the quality engineer determined the plate was in acceptable conforming condition.The available data does not support the complainant¿s description of the complaint condition, and there is no evidence to support the allegation made in the complaint.The complaint condition is unconfirmed or could not be confirmed based on the available data.This lot met all dimensional and visual criteria at the time of release for shipment with no issues documented that would contribute to the complaint condition.Since no manufacturing related issue was identified and/or confirmed, a review to the specific prm and prm line is not applicable.A dimensional inspection was unable to be performed due to not being relevant to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the device was found to have no damage or defects.No definitive root cause could be determined.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.Drawing/specifications reviewed: e current and manufactured dimensional inspection: n/a.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 appropriat.

• Brand Name: 2.4MM LCP PLATE 8 HOLES/64MM-2.0MM THK
• 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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15166881
• MDR Text Key: 304989097
• Report Number: 8030965-2022-05565
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819359840
• UDI-Public: (01)07611819359840
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: VP4022.08
• Device Lot Number: 672P013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 08/17/2022; 09/14/2022
• Supplement Dates FDA Received: 09/12/2022; 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1