MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.030S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date patient pain began is not known.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 the patient underwent an open reduction internal fixation (orif) of the right femur on (b)(6) 2017.The patient underwent removal of one (1) 10mm titanium lateral femoral recon nail, one (1) 5.0mm titanium locking screw with t25 stardrive 48mm, one (1) 5.0mm titanium locking screw with t25 stardrive 54mm and two (2) 6.5mm titanium recon screw with t25 stardrive 100mm on (b)(6) 2018 due to post-operative pain.All the hardware was removed intact.There was no surgical delay and the procedure was completed successfully.Patient outcome was stable.This report is for one (1) 6.5mm recon screw 100mm.This is report 4 of 5 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 history records review was completed for part# 04.003.030s, lot# 8739377.Manufacturing location: mezzovico, release to warehouse date: dec 11, 2013, expiration date: dec 01, 2023.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.The manufacturing documents were reviewed and no complaint related issues were found.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 further reported that nothing new was implanted during surgery on (b)(6) 2018.
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.Event description updated the investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent an open reduction internal fixation (orif) of the right tibia on (b)(6) 2017.The patient underwent removal of one (1) 10mm titanium lateral femoral recon nail, one (1) 5.0mm titanium locking screw with t25 stardrive 48mm, one (1) 5.0mm titanium locking screw with t25 stardrive 54mm and two (2) 6.5mm titanium recon screw with t25 stardrive 100mm on (b)(6) 2018 due to post-operative pain.All the hardware was removed intact.No new hardware was implanted.There was no surgical delay and the procedure was completed successfully.Patient outcome was stable.This report is for one (1) 6.5mm recon screw 100mm.This is report 4 of 5 for (b)(4).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM-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: 7598534
• Report Number: 2939274-2018-52501
• Device Sequence Number: 13736576
• Product Code: HSB
• UDI-Device Identifier: 10886982081643
• UDI-Public: (01)10886982081643
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 04.003.030S
• Device Catalogue Number: 04.003.030S
• Device Lot Number: 8739377
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 06/27/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/03/2018; 07/25/2018
• 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: 19 YR