MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH HEX COUPLING; BIT,DRILL

Model Number	03.130.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on (b)(6) 2020, the prongs of the two (2) depth gauges were broken off at the base, and the front quick coupling portion of the screwdriver separated from the handle.The issue was encountered while cleaning in the sterile processing department (spd).There was no patient involvement.This report is for 1 handle with hex coupling.This is report 3 of 3 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.H3, h4, h6: part: 03.130.005, lot: 9534953, manufacturing site: hägendorf, release to warehouse date: september 18, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the handle with hex coupling was received at us customer quality.Upon visual inspection, it was noticed the device was missing the locking sleeve component.There was no physical damage of the device but the visual inspection revealed that a component was missing thus there is a device failure.Dimensional inspection: a dimensional inspection was not performed due to the definitive finding of a missing component.Document/specification review: drawing(s) reviewed: (manufactured to and current revisions) [assembly], [locking sleeve], [shaft].Conclusion: although the reported allegation stated the device was damaged, the visual inspection of the received handle with hex coupling revealed that there was no physical damage of the device but it was missing instead the locking sleeve component; thus the complaint is confirmed.Although no definitive root-cause can be determined for the missing locking sleeve, it is possible that the missing locking sleeve could occur during the device maintenance (cleaning).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 require.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.
Event or Problem Description
Concomitant devices reported: torque limiter, 0.8 nm, with ao/asif quick coupling, depth gauge for 2.0mm and 2.4mm screws, handle with hex coupling.

• Brand Name: HANDLE WITH HEX COUPLING
• 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: 10015972
• Report Number: 2939274-2020-02163
• Device Sequence Number: 14062629
• Product Code: HTW
• UDI-Device Identifier: 10886982075185
• UDI-Public: (01)10886982075185
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2020

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: 03.130.005
• Device Catalogue Number: 03.130.005
• Device Lot Number: 9534953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/15/2020; 06/09/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/18/2020; 06/10/2020
• 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: DEPTH GAUGE 2.0MM 2.4MM SCR; DEPTH GAUGE 2.0MM 2.4MM SCR; TORQUE LIMIT 0.8 NM W AOASIF QCK CPL