MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.003.028S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that on (b)(6) 2020 during a femoral recon nail procedure, the unknown screws and the unknown drill bit have missed the unknown nail.The reporter commented that the suspected devices were the radiolucent insertion handle and the radiolucent aiming arm.The procedure was completed successfully with a surgical delay of five (5) minutes.There was a minor setback with the unknown drill missing as the outcome of the procedure.This report is for one (1) 6.5mm ti recon screw with t25 stardrive 90mm-sterile.This is report 6 of 6 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.H4, h6: a device history record (dhr) review was conducted: part: 04.003.028s, lot: 5l94151, manufacturing site: mezzovico, release to warehouse date: 14.Oct.2019, expiry date: 31.Aug.2029.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.

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation summary: background: b5: (b)(6) 2020: updated event description: it was reported that during a femoral recon nail procedure, the unknown screws and the unknown drill bit have missed the unknown nail.The case turned out fine.The reporter commented that the suspected devices were the radiolucent insertion handle and the radiolucent aiming arm.The procedure was completed successfully with a surgical delay of five (5) minutes.There was a minor setback with the unknown drill missing as the outcome of the procedure.Concomitant devices reported: protection sleeve(part# 03.010.075, lot# pe03465, quantity: 1), protection sleeve(part# 03.010.075, lot# pe03466, quantity: 1), drill sleeve (part# 03.010.076, lot#pe03467, quantity: 2).This complaint involves six (6) devices.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

(b)(6) 2020: updated event description: it was reported that during a femoral recon nail procedure, the unknown screws and the unknown drill bit have missed the unknown nail.The case turned out fine.It was the reported that the suspected devices were the radiolucent insertion handle and the radiolucent aiming arm.The procedure was completed successfully with a surgical delay of five (5) minutes.There was a minor setback with the unknown drill missing as the outcome of the procedure.Concomitant devices reported: protection sleeve(part# 03.010.075, lot# pe03465, quantity: 1), protection sleeve(part# 03.010.075, lot# pe03466, quantity: 1), drill sleeve (part# 03.010.076, lot#pe03467, quantity: 2).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10595795
• MDR Text Key: 208833871
• Report Number: 2939274-2020-04348
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982081605
• UDI-Public: (01)10886982081605
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.003.028S
• Device Catalogue Number: 04.003.028S
• Device Lot Number: 5L94151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Patient Sequence Number: 1
• Treatment: 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING; 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING; 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING; RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; RADIOLUCENT INSERTION HANDLE FRN; RADIOLUCENT INSERTION HANDLE FRN; UNK - DRILL BITS: TRAUMA; UNK - DRILL BITS: TRAUMA; UNK - NAILS: FEMORAL; UNK - NAILS: FEMORAL; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; RADIOLUCENT INSERTION HANDLE FRN; UNK - DRILL BITS: TRAUMA; UNK - NAILS: FEMORAL; UNK - SCREWS: TRAUMA
• Patient Age: 32 YR