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 Consequences Or Impact To Patient (2199)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review 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 (b)(6) 2018, a depth gauge broke at the base of the long skinnier portion.The incident happened prior to the onset of the procedure when the set was taken out and before the patient was in the room.The patient was not touched by the device.The procedure was successfully completed with the aid of another depth gauge.No surgical time was affected.There was no patient involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm 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.Part: 319.006; synthes lot: 7822746; release to warehouse date october 21, 2014; manufactured by synthes monument.No nonconformance reports (ncrs) were generated during production 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 subcomponents, which would contribute to this complaint condition.Device evaluation: customer quality investigation flow: broken visual inspection: visual inspection observed that the distal needle portion of the depth gauge broke off where the threads of the needle portion are.The break is roughly flush with the depth gauge body.In addition to the break, the needle was also slightly bent.Some surface wear is present but consistent with use.The received condition was determined to agree with the complaint description.During the document/specification review, the following drawings, reflecting the current and manufactured revision, were reviewed.Depth gauge for 2.0/2.4mm screws needle (component).The material of the needle component (part # 319.006.3) is 316leh (l=low carbon, e=extra h=hard) 316 stainless steel (ss)), which is an appropriate material for an instrument component of this type.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dimensional inspection: dimensional inspection of needle component could not be conducted due to the post manufacturing deformation at the break, the location of the break, and because the distal portion of the needle was not received.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.The exact cause of the complaint condition cannot be determined as the handling and use of the device are unknown.However, the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.Investigation conclusion: in conclusion, the complaint condition is confirmed as the needle complaint is broken.No design or manufacturing defect or deficiency was observed during the investigation.Additionally, bending of the needle was observed 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.

• 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: 7929445
• MDR Text Key: 122470780
• Report Number: 2939274-2018-54104
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7822746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1