MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 75MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.003.025S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an orthopedic surgery on (b)(6) 2019, the surgeon was using the lateral entry femoral recon nail (lefn) system and followed the protocol for inserting the two (2) recon screws.After insertion through the drill/protection sleeves within the aiming arm, the two (2) recon screws were outside of the nail (anterior to the nail implant), in the femoral neck and head.The surgeon removed the two (2) screws and had to freehand the screws into the recon slots of the nail.There was a surgical delay of thirty (30) minutes.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: cannulated connecting screw for standard insertion handle (part # 03.010.044, lot # uq55557, quantity # 1); standard insertion handle (part # 03.010.045, lot # 3040015, quantity # 1); protection sleeve for recon locking (part # 03.010.075, lot # 37452a, quantity # 2); wire guide for recon locking (part 03.010.076 , lot # 37453, quantity # 2); recon locking aiming arm for lateral entry femoral nails-ex (part # 03.010.048, lot # 5621601, quantity # 1); titanium lateral entry femoral recon nail-ex/360mm/lt-sterile (part # 04.003.253s, lot # 7498154, quantity # 1).This report is for one (1) 6.5mm ti recon screw with t25 startdrive 75mm-sterile.This is report 2 of 2 for complaint (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.Part 04.003.025s, lot l976070: manufacturing site: mezzovico.Release to warehouse date: august 03, 2018.Expiry date: july 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 75MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8429140
• Report Number: 2939274-2019-57010
• Device Sequence Number: 223057
• Product Code: HSB
• UDI-Device Identifier: 10886982081544
• UDI-Public: (01)10886982081544
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: 04.003.025S
• Device Catalogue Number: 04.003.025S
• Device Lot Number: L976070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 104