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

Model Number	314.31
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review completed for this lot, no nonconformance's found.The dhr shows that this lot was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the holding sleeve (p/n 314.31 lot 4332319) was received with a missing spring subcomponent.Due to the missing spring, the device is unable to function/release/hold as intended.No other issues were identified with the returned components of the device.Document/specification review: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the holding sleeve (p/n 314.31 lot 4332319) as the spring subcomponent was missing.Due to the missing spring, the device is unable to function/release/hold as intended.No definitive root cause could be determined.It is possible that the spring was misplaced during reprocessing, as the device can be disassembled/reassembled.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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) 2019, the holding sleeve was found to be not functioning during a reverse logistics audit of the returned device at millstone.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) holding sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9136783
• Report Number: 2939274-2019-61064
• Device Sequence Number: 16839697
• Product Code: HXX
• UDI-Device Identifier: 10886982188786
• UDI-Public: (01)10886982188786
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: 314.31
• Device Catalogue Number: 314.31
• Device Lot Number: 4332319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1