MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; EXTRACTOR

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown extraction instrument/unknown lot.Part and lot number are unknown; udi number is unknown.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 Description

It was reported that on (b)(6) 2018, the patient underwent a removal of humeral nail.During the revision, the nail was difficult to remove due to the nail extraction device and nail not threading together.It was identified that the devices were not compatible.The nail was from an older system and the extraction device was from a newer system.The correct extraction device was obtained and the procedure was completed successfully.There was a forty-five (45) minute surgical delay due to the unsuccessful attempts of removing the nail with the wrong extraction device.No further issues occurred once the correct instrumentation was obtained.The patient was revised to an unknown eight-hole large fragment plate.Patient status is unknown.Concomitant devices reported: titanium solid humeral nail (part 462.727, lot unknown, quantity 1).This report is for the intra-operative difficulty removing the nail due to having the wrong extraction instrument.The need for the revision procedure is captured on related complaint (b)(4).This report is for an unknown extraction instrument.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.Explantation date reported in initial medwatch report is not applicable for unknown extraction instrument.This date was reported inadvertently in initial medwatch report.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.

• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8202955
• MDR Text Key: 131715388
• Report Number: 2939274-2018-55627
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• 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: 12/06/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR