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

Model Number	355.399S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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.
Additional 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.
Additional 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
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10067265
• Report Number: 2939274-2020-02384
• Device Sequence Number: 678033
• Product Code: HWB
• UDI-Device Identifier: 10886982194961
• UDI-Public: (01)10886982194961
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: 355.399S
• Device Catalogue Number: 355.399S
• Device Lot Number: H869296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 05/28/2020; 06/15/2020; 07/02/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 05/28/2020; 06/16/2020; 07/02/2020
• 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: 63 YR