MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR 90 SCREWDRIVER; SCREWDRIVERS

Model Number	03.505.004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product code: dzj, dzi.The subject device is received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Visual inspection: the handle for 90 screwdriver (part #: 03.505.004, lot #: 8193049) was received at us cq.Visual inspection of the complaint device showed no defect.Functional test: a functional assessment was performed with the complaint device by assembling it to its mating devices (part #: 03.505.003 and 03.505.005).Both assembled correctly with no issue.Consecutively the reminder of the returned devices (except the cases) were assembled together.By turning the tuning handle device, the screwdriver mounted on the distal end of the assembly was able to turn.The entire assembly performed as intended.Investigation conclusion: this complaint is not able to be confirmed as no visual defect was observed on the returned device and the device was able to perform as intended with the mating devices.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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 - a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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, they were unable to sterilize/assemble the gear not matching or was malfunctioning during sterilization.No patient involvement.This report is for one (1) handle for 90° screwdriver.This is report 2 of 4 for complaint (b)(4).

• Brand Name: HANDLE FOR 90 SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12642796
• Report Number: 2939274-2021-06135
• Device Sequence Number: 11616290
• Product Code: HXX
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2021

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: 03.505.004
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8193049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1