MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVESHAFT FOR SCREWDRIVER 90; DRILL, BONE, POWERED

Model Number	03.505.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code dzj.Occupation: reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2020, the drill bit keep coming out to the 90 deg drill, we changed 90 deg drill but same thing happened.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: unk, drill (part #: unknown, lot #: unknown, quantity # :1).This complaint involves four (4) devices.This report is for (1) driveshaft for screwdriver 90°.This is report 3 of 4 (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.G4: the incorrect g4 date was inadvertently utilized in follow-up medwatch 1.The date should have been reported as september 1, 2020.  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 clarified that on (b)(6) 2020, the shaft was kept coming out of the 90 degree drill.Surgeon changed 90 degree drill but same thing happened.There was surgical delay of fifteen (15) minutes.Procedure was successfully completed.Concomitant devices reported: shaft for 90° screwdriver (part # 03.505.003, lot # 08172030, quantity 1); dd - matrixpro ii hand piece (part # 05.000.030, lot # unknown, quantity 2).This report is for one (1) driveshaft for screwdriver 90°.
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.A1: patient identifier: (b)(6).H6: part/lot (03.505.006/8200402) combination are unknown at synthes gmbh, no dhr review possible.H6: 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.

• Brand Name: DRIVESHAFT FOR SCREWDRIVER 90
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10483923
• Report Number: 2939274-2020-03933
• Device Sequence Number: 19143878
• Product Code: DZI
• UDI-Device Identifier: 10887587013329
• UDI-Public: (01)10887587013329
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.505.006
• Device Catalogue Number: 03.505.006
• Device Lot Number: 8200402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 09/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/28/2020; 09/28/2020
• 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: DD - MATRIXPRO II HAND PIECE; SHAFT FOR 90° SCREWDRIVER; SHAFT FOR 90° SCREWDRIVER; UNK - DRILL BITS: TRAUMA
• Patient Age: 72 YR