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

It is unknown when device malfunctioned.Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part number: 319.006, synthes lot number: 6422445, release to warehouse date: 30-jun-2010, (b)(4), no ncrs were generated during production.The needle component dhr was reviewed and the material was confirmed to be correct per 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.A product investigation was conducted.The returned depth gauge was received at us customer quality (cq) with a broken needle component.The needle has broken off at its base of the slider body and was not returned.The received condition of the device agrees with the reported allegation.Therefore this complaint is confirmed for a broken depth gauge needle.Functional test: the broken off depth gauge needle is preventing the depth gauge from functioning as intended, therefore the reported complaint condition is confirmed and was able to be replicated at cq.Dhr review: the returned depth gauge was manufactured in june 2010 and is over 8 years old.No 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 subcomponents, which would contribute to this complaint condition.The needle component dhr was reviewed and the material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Document/specification review: the relevant design drawing(s) were reviewed during this investigation.The depth gauge for 2.0mm and 2.4mm screws (319.006) is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.No product design issues or discrepancies were observed.Dimensional analysis: a relevant dimensional inspection was not able to be performed because the needle broke off at its base and was not returned.The proximal threaded portion of the needle is not accessible for measurement (remains secured within the slider body).Material analysis: the design specified the needle component to be manufactured from 316l extra hard stainless steel material.The needle component dhr was reviewed and the material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Conclusion: the complaint condition is confirmed as the returned 8 year old depth gauge was received with a broken needle.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, unique or different patient harms were identified as a result of this evaluation.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

Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2018, a depth gauge was found to be not working correctly, it was not sliding correctly.The device was found in the warehouse.There were no patient and procedure involvement.During manufacturer¿s investigation of the received device, it was identified that returned depth gauge was received with a broken needle component.The needle has broken off at its base of the slider body and was not returned.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for complaint (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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8016408
• MDR Text Key: 126379484
• Report Number: 2939274-2018-54672
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2018

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: 6422445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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