MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 55MM; GUIDE

Catalog Number	394.45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.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 removal surgery of a broken 5.0mm non-self-drilling schanz pin on (b)(6) 2018, after the staff set the tool properly, the femoral extractor tool's holding sleeves suddenly broke during removal.The parts that broke were the 55mm holding sleeve with the inside screw clamp and the 105mm holding sleeve with the inside screw clamp.These parts were attached to the guide pins located in the patient.The surgeon had no way to remove the clamp with the broken screw still inside the sleeve's hole.He decided to remove the guide pin completely with the broken clamp.They discarded all items in the waste bin during the surgery.There was a five (5) minute surgical delay.The surgery was finished with no further issues.The patient outcome is unknown.Concomitant device: guide pins (part: unknown, lot: unknown, quantity: 2).This report is for a holding sleeve 55mm.This is report 1 of 2 for (b)(4).

• Brand Name: HOLDING SLEEVE 55MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8013700
• Report Number: 2939274-2018-54655
• Device Sequence Number: 16538785
• Product Code: FZX
• UDI-Device Identifier: 10886982199737
• UDI-Public: (01)10886982199737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 394.45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 100