MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION HOOK - STERILE FOR TI CANNULATED NAILS; EXTRACTOR

Model Number 355.399S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this 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.

Event Description

It was reported that on (b)(6) 2020, during removal of proximal femoral nailing system (tfna) long nail and the titanium helical blade, the surgeon removed one (1) distal interlock 5.0mm locking screw and put extraction instrument on the helical blade they then connected the extraction bolt to the proximal instrumented end of the tfna removed the helical blade.They extracted the broken proximal end then proceeded to attempt to remove the distal broken portion of the tfna nail with an extraction hook with no success for 2-3 hours.Then moved to the distal femur to make an opening hole distal to the nail so they can drive out the nail from the distal (retrograde) end.They proceeded in driving the nail until the instrumented proximal portion of the nail was exposed outside of the soft tissue.They put the extraction hook back into the nail and pulled it completely out.It is unknown there was a surgical delay.The procedure was successfully completed.The patient outcome was good.This (b)(4) captures the intraoperative event that during removal there was an additional intervention that was required to remove nail while, this (b)(4) captures the ops-operative event that the broken proximal femoral nailing system (tfna) long nail and the titanium helical blade were removed due to delayed healing and non-union.This complaint involves two (2) devices this report is for one (1) extraction hook - sterile for ti cannulated nails.This report is 2 of 2 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.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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d6: implant date provided for reporting.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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: lot is unknown.Previously reported lot is incorrect e1 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: EXTRACTION HOOK - STERILE FOR TI CANNULATED NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10067265
• MDR Text Key: 192151044
• Report Number: 2939274-2020-02384
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982194961
• UDI-Public: (01)10886982194961
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 355.399S
• Device Catalogue Number: 355.399S
• Device Lot Number: H869296
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR