MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE, DEPTH

Model Number 03.010.072

Device Problems Break (1069); Material Discolored (1170); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was 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.

Event Description

It was reported that during sterile processing on (b)(6) 2020, the paint or white calibrated etching of four (4) depth gauge for locking screws were noticed to had faded away after decontamination and four (4) depth gauge for locking screws had missing ball bearings that help provide stability to the depth gauge.Without the bearing, the two pieces fall apart easily.There was no patient involvement.This complaint involves eight (8) devices.This is 4 of 4 for report (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.H10 additional narrative: h3, h4, h6 investigation summary.Visual inspection: the depth gauge for locking screws to 100mm for im nails (p/n: 03.010.072, lot number: 3759325) was received at us cq.Upon visual inspection, the device was missing the ball bearing and spring components, and the device tip was bent/deformed.There was no evidence of discoloration.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: hook diameter = 2.5 +0/-0.1 mm.Measured dimensions: hook diameter = 2.46mm, conforming; device used ¿ caliper ca215p.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the depth gauge is missing the ball bearing and spring components and has a bent tip.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: part: 03.010.072; lot: 3759325; manufacturing site: (b)(4); release to warehouse date: 04.May.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 LOCKING SCREWS TO 100MM FOR IM NAILS
• 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: 9647952
• MDR Text Key: 191542054
• Report Number: 2939274-2020-00557
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: (01)10886982067449
• 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
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: 3759325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1