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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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, while inspecting the set after it was washed, it was noticed that the stick of the depth gauge was broken off.The depth gauge was used in a surgery earlier in the day but was not broken while it was being used.There was no patient involvement.This report is for a depth gauge.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: a device history record (dhr) review was conducted: part # 319.006.Synthes lot # ft00443.Supplier lot # ft00443.Release to warehouse date: 15may2017.Supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No non-conformance reports (ncr's) were generated during production.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.A product investigation was conducted.Device condition: visual inspection performed at customer quality observed broken needle on the returned depth gauge.The needle of the depth gauge is broken off at the interface to the slider body.All remaining components of the depth gauge showed minimal signs of wear.This is consistent with the reported complaint condition.The device condition agree with the complaint description and the complaint was confirmed.The cause for this complaint condition cannot be definitely determined to be use error, misuse/abuse, non-compliance, or postoperative trauma.Dimensional analysis and document/specification review: relevant drawings for the returned device (both current revision and from the time of manufacture) were reviewed, and no design issues were noted.Dimensional inspection: needle shaft specification: ø 1.25 +0/- 0.05 mm, needle measured dimensions: shaft ø: 1.25 mm; conforming while no definitive root cause could be determined, it is possible that any unintended excessive forces such as device being dropped during usage/handling could have contributed to complaint condition.The material used during production was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Conclusion: the overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device manufacture date: : the device has been 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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: 7953369
• MDR Text Key: 123400329
• Report Number: 2939274-2018-54290
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• 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
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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: FT00443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1