MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.029
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Complainant part is not expected to be returned for manufacturer review/investigation.Additional 510k code: k040336.(b)(4) used for: the screw was found to be too long postoperatively on x-ray but did not penetrate.The surgeon took the patient back into surgery where the screw were backed out a small amount.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
T was reported that the patient was implanted with one (1) recon-nail and two (2) recon-screws during a hip surgery on (b)(6) 2018.It was noticed with the help of post-operative x-rays, that the recon screws seemed too long, so the surgeon brought the patient back to the surgery on (b)(6) 2018 to back the screws out a couple of turns.The surgery was completed successfully without any delay.The patient status was reported to be fine at the end of the procedure.This complaint involves two (2) devices.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 used for treatment, not diagnosis.Event date was when patient was implanted with one (1) recon-nail and two (2) recon-screws during a hip surgery on (b)(6) 2018.Alert date changed to reflect update received from sc.Device used for treatment, not diagnosis.Investigation summary: product was not returned.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.

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
• 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: 7452558
• Report Number: 2939274-2018-51871
• Device Sequence Number: 13761538
• Product Code: HSB
• UDI-Device Identifier: 10886982081612
• UDI-Public: (01)10886982081612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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 Model Number: 04.003.029
• Device Catalogue Number: 04.003.029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 43 YR