MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE WITH LOCKING DEVICE; SCREWDRIVERS

Model Number	03.010.112
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The 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 on an unknown date, during routine incoming inspection, it was observed that the holding sleeve was missing a piece.There was no known patient or hospital involvement.This complaint involves one (1) holding sleeve with locking device.This is 1 of 1 for report (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, h6 investigation summary: device history lot: part # 03.010.112; synthes lot number: 4786968; manufacturing site: synthes brandywine; release to warehouse date: 13-oct-2004.Device history review (dhr): 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.Visual inspection: holding sleeve with locking device was received at us customer quality (cq).Upon visual inspection at cq, it is observed that the component, spring is missing from the assembly of the device.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is confirmed.Device failure/ defect found? yes.Dimensional inspection: the dimensional inspection was not performed as the device was found to be missing spring from the assembly during visual inspection.Document/specification review: respective drawings were reviewed during the investigation.No design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: a visual inspection and document/specification review were performed as part of this investigation.The complaint is confirmed as the device was found to be missing a component, spring from the assembly of the device.While a definitive root cause could not be determined, it is possible that the spring might have got misplaced during sterile processing.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based on these results, 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 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: HOLDING SLEEVE WITH LOCKING DEVICE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9217684
• Report Number: 2939274-2019-61654
• Device Sequence Number: 2740000
• Product Code: HXX
• UDI-Device Identifier: 10886982067845
• UDI-Public: (01)10886982067845
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 10/02/2019

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: 03.010.112
• Device Catalogue Number: 03.010.112
• Device Lot Number: 4786968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1