MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE, DEPTH

Model Number 319.091

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, there were two gauges were found metal probe broken off and metal probe bent out of shape.It was unknown how and when damages happened.There was no procedure and patient involvements are reported.This complaint involves two (2) devices.This report is for (1) depth gauge for 3.5mm cortex screws.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary.Investigation flow: damage.Visual inspection: the depth gauge for 3.5mm cortex screws (part #: 319.091, lot #: 4250320) was received at us cq.Upon visual inspection, the needle was bent.Device failure/defect was identified.Document/specification review: no design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the needle of the depth gage was bent.Although no definitive root cause could be determined based on the provided information; it is likely that the device encountered unintended forces.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 preventive 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 # 319.091.Synthes lot # 4250320.Supplier lot # n/a.Release to warehouse date: mar 22, 2001.Manufacturer: brandywine.No ncr's 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.

• Brand Name: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12053282
• MDR Text Key: 258148582
• Report Number: 2939274-2021-03180
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982190000
• UDI-Public: (01)10886982190000
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.091
• Device Catalogue Number: 319.091
• Device Lot Number: 4250320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/21/2021
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS