MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	04.402.006S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.Device was used for treatment, not diagnosis.If information is obtained that was not available.
Event or Problem Description
It was reported that on (b)(6) 2015, patient was implanted with a radial prosthesis.On (b)(6) 2018, the implant was removed due to the radial stem becoming loose.Implant was not replaced.There was no report of patient harm.Concomitant devices reported: 18mm cocr radial head standard height/11.5mm-sterile (part# 09.402.018s, lot# 7838259, quantity 1).This report is for one (1) 6mm ti straight radial stem 24mm-sterile.This is report 1 of 1 for (b)(4).
Additional 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.Device history records review was completed for part# 04.402.006s, lot# 7785140.Manufacturing location: monument, manufacturing date: apr 15, 2015, expiry date: mar 31, 2020.Raw material part 21014 lot 7557656 was reviewed.Certificate of compliance received for ti from avalign met specification.Inspection sheet - incoming final inspection met inspection acceptance criteria.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Product development investigation was completed.The reported complaint condition of loosening could not be confirmed at customer quality (cq) because no visual evidence of the device being loose in-situ was provided.Furthermore, there is no evidence on the returned part that indicates or confirms that a loosening occurred.Visual inspection under 5x magnification at cq revealed minor wear consistent with implantation and explantation.Whether this complaint can be replicated at cq via functional test is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.This complaint is unconfirmed as no x-rays or evidence was provided.Relevant actions have been taken to address the issue.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: 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE
• Common Device Name: 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: 7437770
• Report Number: 2939274-2018-51784
• Device Sequence Number: 1030590
• Product Code: KWI
• UDI-Device Identifier: 10886982128034
• UDI-Public: (01)10886982128034
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 04.402.006S
• Device Catalogue Number: 04.402.006S
• Device Lot Number: 7785140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1124-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 86