MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & LARGER SCREWS WITH ZERO OFFSET; GAUGE, DEPTH

Model Number 03.501.001

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 03.501.001; lot: l127895; manufacturing site: (b)(4).Release to warehouse date: 21.Oct.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the depth gauge for 2.7mm & larger screws with zero offset (p/n: 03.501.001, lot number: l127895) was received at us customer quality (cq).Upon visual inspection it was noticed that the needle component was bent.Dimensional inspection: the diameter of the needle component was measured to check the dimensional accuracy.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for the depth gauge for 2.7mm & larger screws with zero offset (p/n: 03.501.001, lot number: l127895) as the needle component was bent.No new, unique, or different patient harms were identified as a result of this evaluation.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 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 a routine incoming inspection of a loaner set, the depth gauge was observed bent.There were no patient, and surgical involvement.This report is for one (1) depth gauge for 2.7mm & larger screws with zero offset.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM & LARGER SCREWS WITH ZERO OFFSET
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10733539
• MDR Text Key: 213010055
• Report Number: 2939274-2020-04812
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10887587010519
• UDI-Public: 10887587010519
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.501.001
• Device Catalogue Number: 03.501.001
• Device Lot Number: L127895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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