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 Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.This is a veterinary facility, so no patient information would be reported if there was patient involvement.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 it was discovered there was a broken part on a depth gauge.It was noted the device was loose and broken when received from shipment.There was reportedly no patient involvement.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.H3, h4, h6: a device history record (dhr) review was conducted.Part # 319.006 , synthes lot # h521667 , supplier lot # h521667 , release to warehouse date: 08may2018 , supplier: (b)(4).The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No non-conformance reports (ncrs) 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.H3, h6: a product investigation was conducted.Visual inspection: the device (part # 319.006, lot # h524667, mfg 08-may-2018) was received at us cq with all of the pieces of the depth gauge showing minimal signs of wear.The needle of the depth gauge is not broken but bent at the point where the needle screws into the slider of the depth gauge.This is not consistent with the reported complaint condition; therefore, the complaint is not confirmed for a broken depth gauge.However, the complaint is confirmed for a bent depth gauge needle.Dimensional inspection: dimensional analysis was completed, the major thread diameter measured.This is within the specification per relevant drawing and per tolerance specified in iso 724 (second edition,1993-10-15.) document/specification review: the relevant drawing(s) was reviewed; the material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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.Conclusion: the complaint condition is confirmed as the device (part # 319.006, lot # h524667) was received with the needle bent.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off axis or damaged during sterile processing).No new malfunctions were observed during the course of 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.

• 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: 7865331
• MDR Text Key: 119937992
• Report Number: 2939274-2018-53739
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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: H521667
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) 2018