MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE/6 HOLE/RIGHT/85MM; PLATE,FIXATION,BONE

Model Number 02.112.080

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.Investigation summary: investigation flow: damage.Visual inspection: the 3.5mm lcp superior clavicle plate/6 hole/right/85mm (p/n: 02.112.080, lot number: 51p9104) was received at us cq.Upon visual inspection, the plate was slightly bent at the mid point between the first and second combi hole (hole b & c) according to drawing.Deep scratches were noticed on the posterior surface of the plate in the area where the bending occurred.The internal thread of the combi holes did not present any damage.The device was received without any packaging.Device failure/defect identified? yes.Dimensional inspection: drawing.Specified dimensions: small end hole diameter.Combi hole diameter, measured dimensions: small end hole diameter = conform.Combi hole diameter = conform.Device used ¿ pin gage set gp29 and gp 32.Document/specification review: drawing: (current and manufactured) was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the reported condition as the packaging being damaged could not be confirmed as the device was received without any packaging material.However the overall complaint is confirmed as the visual inspection performed on the 3.5mm lcp superior clavicle plate/6 hole/right/85mm (p/n: 02.112.080, lot number: 51p9104) revealed that the plate was slightly bent at the mid point between the first and second combi hole (hole b & c) and the area of the bending had deep scratches.No definitive root cause could be attributed to this allegation but it is likely that the issue occurred during transit as the damage was noticed upon delivery of the device.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: august 12, 2020 by: (b)(6).Part number: 02.112.080-us.Lot number: 51p9104.Part manufacture date: april 15, 2020.Manufacturing location: elmira.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 3.5mm lcp superior clavicle 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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material 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 history review: 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.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 that on (b)(6) 2020, the 3.5mm locking compression plate (lcp) superior clavicle plate was noticed to be damaged upon delivery.The product packaging ripped and plate scratched.The package envelope was also damaged and the locking hole appeared to be damaged.There were no patient or surgical involvement.This report is for one (1) 3.5mm lcp superior clavicle plate/6 hole/right/85mm.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.G1: physical manufacturer updated.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 LCP SUPERIOR CLAVICLE PLATE/6 HOLE/RIGHT/85MM
• 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: 10484757
• MDR Text Key: 206480629
• Report Number: 2939274-2020-03938
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982033093
• UDI-Public: (01)10886982033093
• Combination Product (y/n): N
• PMA/PMN Number: K111540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.112.080
• Device Catalogue Number: 02.112.080
• Device Lot Number: 51P9104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/04/2020
• Patient Sequence Number: 1