MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM; PLATE,FIXATION,BONE

Model Number 02.112.018

Device Problems Material Twisted/Bent (2981); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted: investigation flow: damage.Visual inspection: the 3.5mm lcp sup ant clavicle pl w/lat extn 7h/rt/123mm (p/n: 02.112.018, lot number: 6381742) was received at us cq.Visual inspection of the complaint device showed scratches along the device, and the first combi hole (marked ¿a¿ on the current drawing revision) had damaged threads.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection could be due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate was scratched.Additionally, the first combi hole had damaged threads.No definitive root cause could be determined based on the provided information.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 preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: device history review done on (b)(6) 2020.Part number: 02.112.018.Lot number: 6381742.Part manufacture date: may 10, 2010.Manufacturing location: (b)(4).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 this lot of 3.5mm lcp sup ant clavicle plates was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of 24 pieces 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 device history record for the raw material revealed no complaint related anomalies.The 8 parts scrapped at op 0020 ¿ lims inspection are unrelated to the complaint condition.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: the lot quantity of (b)(4) pieces 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 during a routine incoming inspection of a loaner set at fsl ups (b)(4) site on an unknown date, the locking compression plate (lcp) superior anterior clavicle plate was observed damaged with a scratched plate.There were no patient and surgical involvement.This complaint involves 1 device.This report is for (1) 3.5mm lcp sup ant clavicle pl w/lat extn 7h/rt/123mm.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.H10 additional narrative: d4.H11 corrected data: h6.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 SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM
• 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: 10335654
• MDR Text Key: 200836973
• Report Number: 2939274-2020-03313
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982032713
• UDI-Public: 10886982032713
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.112.018
• Device Catalogue Number: 02.112.018
• Device Lot Number: 6381742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/08/2020
• Patient Sequence Number: 1