MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE

Model Number	04.402.027S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of event: unknown.Original implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review was conducted.The report indicates that the: manufacturing location: supplier (b)(4), packaged by: (b)(4).Manufacturing date: 28-aug-2014.Expiration date: 30-jun-2019.Part #: 04.402.027s, lot#: 7607072 (sterile) - 7 mm ti curved radial stem 42 mm-sterile.Quantity 131.Raw material part no: 21069 lot number- 5490857 reviewed.Certificate of test for titanium raw material received from (b)(4) and raw material inspection sheet meet specification.Raw material receiving/putaway checklist meet specification.Inspection sheet for incoming final inspection (b)(4) rev: b meet inspection criteria.Certificate of compliance from (b)(4) for titanium meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4).¿sterility documentation was reviewed and determined to be conforming.¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary: product was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent removal of a radial head and stem prosthesis on (b)(6) 2018.The removal was completed successfully with no patient harm.The patient was not revised to anything following the procedure.It is unknown why the devices were removed.The sales consultant believes it may have been due to a patients complaint of pains.This report involves 2 devices.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Event date is unknown as it is unknown why the device was removed.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: 7MM TI CURVED RADIAL STEM 42MM-STERILE
• Common Device Name: 7MM TI CURVED RADIAL STEM 42MM-STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7379569
• Report Number: 2939274-2018-51290
• Device Sequence Number: 1637167
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096(17)190630(10)7607072
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/24/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7607072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 63