MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

Catalog Number 319.006

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary background: it was reported that on an unknown date, during routine incoming inspection of loaner set it was observed that the depth gauge was missing a piece.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (part # 319.006/ lot # h363284) was received at us cq.The needle of the device was broken off and was not returned.The ball component was missing from the body.No other defects were identified.The received condition was consistent with the complaint condition thus the complaint was confirmed.Needle was broken, ball was missing.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Conclusion: the overall complaint was confirmed for the received depth gauge for 2.0mm and 2.4mm screws as the needle was broken and the ball was missing.Although no definitive root-cause can be determined its possible the device experienced unintended forces leading to the device breakage.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.A review of the device history record.Device history lot: part #: 319.006.Synthes lot number: h363284.Supplier lot number: h363284.Manufacturing site: synthes monument.Release to warehouse date: 21-nov-2017.Supplier: (b)(6).Device history batch null, device history 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 an unknown date, during routine incoming inspection of loaner set it was observed that the depth gauge was missing a piece.There was no patient involvement.This complaint involves one (1) device.

Manufacturer Narrative

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.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 2.0MM AND 2.4MM SCREWS
• Type of Device: DEPTH GAUGE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9766139
• MDR Text Key: 191684197
• Report Number: 2939274-2020-01096
• Device Sequence Number: 1
• Product Code: HTJ
• 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
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: H363284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/28/2020
• Patient Sequence Number: 1