MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOW PROFILE CURVED RECON PLATE 88MM RADIUS 14 HOLES; PLATE, FIXATION, BONE

Model Number 245.914

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: ktt.Occupation: reporter is a j&j sales representative.The subject 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.

Event Description

It was reported on (b)(6) 2021, upon opening the package for a set to fill in, it was noticed that the bend of a low profile curved reconstruction plate was not correct.There was no patient involvement.This report is for one (1) 3.5mm low profile curved recon plate 88mm radius 14 holes.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.The complaint is not confirmed as 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.It was concluded no damage, breakage, gouges/scratches, or out-of-specification conditions due to damage occurred after the product left manufacturing.No definitive root cause can be determined based on the provided information.Since no manufacturing-related issue was identified and/or confirmed, a review to the specific prm and prm line is not applicable.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 :04-aug-2021 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.Part number: 245.914-us.Lot number: 82p2316.Part manufacturing date: 18 december 2020.Manufacturing site: elmira.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 82p2316 of 3.5 mm low profile curved recon 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 raw material device history record(s) determined the raw material lot 22p4036 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.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.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: 3.5MM LOW PROFILE CURVED RECON PLATE 88MM RADIUS 14 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12333447
• MDR Text Key: 266963051
• Report Number: 2939274-2021-04709
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982170385
• UDI-Public: (01)10886982170385
• Combination Product (y/n): N
• PMA/PMN Number: K031573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 245.914
• Device Catalogue Number: 245.914
• Device Lot Number: 82P2316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1