MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM

Model Number	03.019.029
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The depth probe for multi loc humeral nailing system (part #: 03.019.029, lot #: unknown) was received at us cq.Upon visual inspection, the device shaft was bent and the sleeve was missing.No other issues were identified with the returned device.This complaint is confirmed as the device was missing sleeve and the shaft was bent.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.However, the potential cause could be due to unintended forces applied to the device and the missing sleeve is likely due to disassembly during cleaning/sterilization based on the investigation findings, it has been determined that 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.
Event or Problem Description
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth probe for multiloc humeral nailing system was missing a piece.There was no known patient or hospital involvement.This report is for one (1) depth probe for multiloc humeral nailing system this is report 1 of 1 for (b)(4).

• Brand Name: DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: PROBE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10601282
• Report Number: 2939274-2020-04387
• Device Sequence Number: 11526695
• Product Code: HXB
• UDI-Device Identifier: 10886982069696
• UDI-Public: (01)10886982069696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 03.019.029
• Device Catalogue Number: 03.019.029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1