MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE, DEPTH

Model Number 03.010.072

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03.010.072, lot number: l283434) was returned to cq west chester for investigation.The depth gauge was deformed close to the hook.No other issues were identified.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Measuring device used: ca122 (caliper).Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the depth gauge was found deformed near the hook during visual inspection.Hence, the complaint was confirmed, a definitive root cause cannot be determined from the provided information.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 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 history lot, part #: 03.010.072, synthes lot #: l283434, release to warehouse date: 12 may 2017.Manufactured by: (b)(4).No ncrs were generated during production.Device history review 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.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 october 19, 2021, three (3) depth gauges were found to be broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement and no additional information is available.This report is for one (1) depth gauge for locking screws to 100mm for im nails.This is report 2 of 3 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• Type of Device: GAUGE, DEPTH
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12804100
• MDR Text Key: 286064584
• Report Number: 2939274-2021-06656
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: 10886982067449
• 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: Other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: L283434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• 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