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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 03/29/2018

Event Type  Injury  

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 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).

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
• 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: 7452558
• MDR Text Key: 106247905
• Report Number: 2939274-2018-51871
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982081612
• UDI-Public: (01)10886982081612
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.003.029
• Device Catalogue Number: 04.003.029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR