MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 90 DEGREE SCREWDRIVER BPD ADAPTER; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	SD03.505.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that during an open reduction internal fixation (orif) of a rib fracture on (b)(6) 2020, the handle for 90 degrees screwdriver and adaptor for the 90 degrees screwdriver bound up together.The procedure was successfully completed with the manual 90 degree screwdriver.There was a ten (10) minutes surgical delay reported.Patient status is unknown.This report is for one (1) 90 degree screwdriver bpd adapter.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the 90 degree screwdriver bpd adapter (part # sd03.505.006 / lot # h792900) and handle for 90° screwdriver (part # 03.505.004 / lot # 8145704) was received at us cq.Both devices were received mated together.There were no visual defects on the exterior of the devices, it was unable to determine if other visual defects were present in the internal features of the devices as the devices could not be separated.The overall complaint was confirmed for the received 90 degree screwdriver bpd adapter.Although no definitive root-cause can be determined its possible there was an internal mechanical failure.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part #: sd03.505.006.Synthes lot number: h792900.Supplier lot #: h792900.Release to warehouse date: (b)(6) 2019.Supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 90 DEGREE SCREWDRIVER BPD ADAPTER
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10463448
• Report Number: 2939274-2020-03848
• Device Sequence Number: 16948564
• Product Code: HWE
• UDI-Device Identifier: 10887587074221
• UDI-Public: (01)10887587074221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: SD03.505.006
• Device Catalogue Number: SD03.505.006
• Device Lot Number: H792900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: HANDLE FOR 90° SCREWDRIVER