MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STEM EXTRACTOR F/GUIDE BAR 03.401.070

Catalog Number	03.401.072
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 or Problem Description
It was reported that during arthroplasty on (b)(6) 2018, the stem extractor/guide bar broke.The stem extractor was hooked to the stem.Using the slap hammer and guide, the surgeon repeatedly struck the slap hammer against the back stop on the top of the guide.After several dozen strikes, the connecting screw attaching the stem extraction device and the slap hammer broke.The surgeon removed the implant head and left the stem in before closing.The patient was referred to a specialist.There was surgical delay of approximately one hour due to the extraction device breaking.Patient outcome is unknown.Concomitant devices: stem/guide (part: unknown, lot: unknown, quantity: 1); slap hammer (part: unknown, lot: unknown, quantity: 1).This report is for a stem extractor for guide bar.This is report 1 of 1 for (b)(4.
Additional Manufacturer Narrative
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: STEM EXTRACTOR F/GUIDE BAR 03.401.070
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7893326
• Report Number: 2939274-2018-53887
• Device Sequence Number: 19181051
• Product Code: HWB
• UDI-Device Identifier: 10886982079824
• UDI-Public: (01)10886982079824
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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 Catalogue Number: 03.401.072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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-1514-2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention