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

Model Number 03.019.029

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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
• Type of Device: PROBE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10601282
• MDR Text Key: 209021113
• Report Number: 2939274-2020-04387
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10886982069696
• UDI-Public: (01)10886982069696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1