MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR; SCREWDRIVER

Model Number	03.501.750
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
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 matrixrib scrdrvr bld slf-rt 90 scrwdrvr (part #: 03.501.750, lot #: u373067) 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).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 - no ncrs were generated during production.Device history review - 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.
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) matrixrib scrdrvr bld slf-rt 90 scrwdrvr.This is report 3 of 4 for complaint (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: h4: part # 03.501.750.Synthes lot # u373067.Supplier lot # u373067.Release to warehouse date: february 19, 2021.Supplier: (b)(4).No ncrs were generated during production.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: MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12642840
• Report Number: 2939274-2021-06136
• Device Sequence Number: 3413485
• Product Code: HXX
• UDI-Device Identifier: 10887587011424
• UDI-Public: (01)10887587011424
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• 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: 03.501.750
• Device Catalogue Number: 03.501.750
• Device Lot Number: U373067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.2 DB 6 STOP 90 SCRWDRVR MATRIXRIB; 2.2 DB 6 STOP 90 SCRWDRVR MATRIXRIB; HANDLE FOR 90 SCREWDRIVER; HANDLE FOR 90 SCREWDRIVER; INSTRUMENT TRAY FOR 90 SCREWDRIVER; MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR; MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR; MOD F/MATRIXRIB INST FOR 90 SCRDRIVER; SHAFT FOR 90 SCREWDRIVER; SHAFT FOR 90 SCREWDRIVER
• Patient Sex: Unknown