MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIAL HEAD REPLACEMENT INSTR KIT; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number 03.405.000S

Device Problem Break (1069)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

It was reported that on (b)(6) 2020 while doing a radial head replacement, after using the palner, it was discovered that small pieces of white plastic had come off during the planning process.All of the noticeable pieces were removed and the area was irrigated.The procedure was successfully completed with a five (5) minute of surgical delay.The patient outcome is unknown.This report is for one (1) radial head replacement instrument kit, sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9 h3, h6: part number:03.405.000s.Synthes lot number: 6976191.Supplier lot number: n/a.Release to warehouse date: july 15, 2020.Expiration date: may 31, 2025.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: radial head replacement instr kit (part# 03.405.000s, lot# 6976191, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the bottom of the planer component from the kit was slightly broken.The fragments generated were not returned at cq.Rest of the kit looks good without any damage.Thus, the complaint confirmed.Device failure / defect identified? yes.Dimensional inspection: a dimensional inspection was not performed at cq due to the design and geometry of the device.Document/specification review: the following drawings were reviewed during the investigation: planer for radial neck.Radial head replacement instrument kit-sterile no design issues or discrepancies were noticed.Complaint confirmed? yes.Investigation conclusion the complaint condition was confirmed for the radial head replacement instr kit (part# 03.405.000s, lot# 6976191).A definitive root cause for the reported problem cannot be determined.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.D1.

• Brand Name: RADIAL HEAD REPLACEMENT INSTR KIT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11170302
• MDR Text Key: 226860241
• Report Number: 2939274-2021-00300
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982300829
• UDI-Public: 10886982300829
• Combination Product (y/n): N
• PMA/PMN Number: K183618
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.405.000S
• Device Catalogue Number: 03.405.000S
• Device Lot Number: 6976191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 67