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 Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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 an unknown procedure on (b)(6) 2020 the depth gauge for locking screws was bent so badly that it had to be cut out to be removed.It is unknown if there was a surgical delay.There was no patient consequence reported.Surgical outcome is unknown.This report is for one (1) depth gauge for locking screws to 100mm for im nails.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.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- the depth gauge for locking screws to 100mm for im nails (part #: 03.010.072, lot #: 9872637) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the complaint device was bent.No other issues were identified with the returned device.The complaint condition was confirmed for the depth gauge for locking screws to 100mm for im nails (part #: 03.010.072, lot #: 9872637) as the tip of the complaint device was bent.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use.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 lot part: 03.010.072 lot: 9872637 manufacturing site: hägendorf release to warehouse date: 05.Jul.2016 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: 10432123
• MDR Text Key: 203701352
• Report Number: 2939274-2020-03685
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• 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: 9872637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention