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

Part: 319.006; synthes lot: 7971080; supplier lot: na; release to warehouse date: april 08, 2015; manufactured by synthes (b)(4).No nonconformance 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.Investigation flow: broken: device condition: visual inspection performed at customer quality observed broken needle on the returned depth gauge and a missing ball bearing on the slider body.The needle of the depth gauge is broken off right at the slider body.The ball bearing is missing and was not returned, the hole on the slide body is deformed.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.Final assembly needle dimensional inspection: needle shaft specification: ø 1.25 +0/- 0.05 mm ; needle measured dimensions: shaft ø: 1.25 mm; conforming.Dimensional inspection of the ball bearing and slider body hole cannot be performed due to the damage to the slider body and the missing ball bearing.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.

Event Description

It was reported that during a routine inspection on an unknown date, it was discovered that the ball bearing was missing from the slider body of the depth gauge.There was no patient/procedure involvement.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8037280
• MDR Text Key: 126088461
• Report Number: 2939274-2018-54764
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2018

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: 7971080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1