MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE U; GAUGE,DEPTH

Model Number 319.09

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, 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

It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge for small screws was broken.There was no patient or hospital involvement.This complaint involves one (1) device.This report is for one (1) depth gauge for small screws.This is report 1 of 1 for (b)(4).

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.The depth gauge f/long-scr ø3.5 meas-range u (p/n 319.090-us lot 5l28500) was received showing a bent distal needle tip.No other issues were identified with the returned components of the device.The complaint is not confirmed as the device in not broken in 2+ pieces.An accurate dimensional inspection of the device was not able to be performed because of the post manufacturing deformation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The complaint condition is not confirmed for the depth gauge f/long-scr ø3.5 meas-range u (p/n 319.090 lot 5l28500).The device was received showing a bent distal needle tip.While no definitive root cause could be determined for the bent needle, it is possible that the device encountered unintended forces.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot.Product code: 319.090.Lot #: 5l28500.Manufacturing site: bettlach.Release to warehouse date: 18.July 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

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.A review of the device history record.The device was received, the investigation is in progress, 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.

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.Visual inspection: the depth gauge f/long-scr ø3.5 meas-range u (p/n 319.090 lot 5l28500) was received showing a bent distal needle tip.No other issues were identified with the returned components of the device.The complaint is not confirmed as the device in not broken in 2+ pieces.Device failure/defect identified? yes - the device failure/defect of a bent needle was identified during investigation.Dimensional inspection: an accurate dimensional inspection of the device was not able to be performed because of the post manufacturing deformation.Document/specification review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint condition is not confirmed for the depth gauge f/long-scr ø3.5 meas-range u (p/n 319.090 lot 5l28500).The device was received showing a bent distal needle tip.While no definitive root cause could be determined for the bent needle, it is possible that the device encountered unintended forces.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot.Product code: 319.090, lot #: 5l28500, manufacturing site: bettlach, release to warehouse date: july 18, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 F/LONG-SCR Ø3.5 MEAS-RANGE U
• 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: 9280668
• MDR Text Key: 191039752
• Report Number: 2939274-2019-61982
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189998
• UDI-Public: (01)10886982189998
• 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,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.09
• Device Catalogue Number: 319.090
• Device Lot Number: 5L28500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1