MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW; BIT, DRILL

Model Number	03.207.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a slipped capital femoral epiphysis (scfe) procedure on an unknown date, the surgeon encountered an issue with the drill bit where it was binding and pushing on the guide wire along with the drill bit.The left hip was done first.The surgeon reported that the guidewire pushed the femoral head and into the acetabular area; although, it was not sure if the acetabulum was completely penetrated.It was mentioned that the same drill bit was problematic on the contra lateral side; the surgeon had to be extra careful to ensure that the same issue would not occur.It was noted that during the procedure four (4) guide wires bent; however only one of the wires penetrated the acetabulum on the right hip.The procedure was successfully completed despite the drill bit issue.There was a thirty to forty-five (30-45) minute surgical delay reported.Concomitant device reported: scfe screw (part 02.207.626, lot unknown, quantity 1), scfe screw (part 02.207.625, lot unknown, quantity 1), oval washer (part 02.207.637, lot unknown, quantity 1).This report is for a drill bit.This is report 1 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.Part 03.207.008, lot pe02780: release to warehouse date: october 20, 2016.Supplier : (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was completed: visual inspection observed that no issues with the instrument.Nothing was bent or worn.A device failure was not identified.Dimensional inspection showed the relevant dimensions were conforming.The relevant drawings were reviewed.Based on the review of the drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The exact cause of the complaint condition cannot be determined as no issues were noted and therefore the complaint is unknown.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
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 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: 5.0MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8944773
• Report Number: 2939274-2019-60191
• Device Sequence Number: 19370806
• Product Code: HTW
• UDI-Device Identifier: 10886982075987
• UDI-Public: (01)10886982075987
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2019

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: 03.207.008
• Device Catalogue Number: 03.207.008
• Device Lot Number: PE02780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 09/04/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/04/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCFE SCR Ø7.3 CANN L80/20; SCFE SCR Ø7.3 CANN L85/20; WASHER Ø18 OVAL T2 F/SCFE SCREW; SCFE SCR Ø7.3 CANN L80/20; SCFE SCR Ø7.3 CANN L85/20; WASHER Ø18 OVAL T2 F/SCFE SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 100