MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL SLEEVE 42MM LONG; GUIDE, SURGICAL, INSTRUMENT

Model Number SD312.021

Device Problems Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2021, during an unknown procedure the drill sleeve top hat broke, the retrograde/antegrade femoral nail (rafn) entry reamer is dull, the drive adaptor with qc for 5.0mm schanz screws and drive adaptor with qc for 6.0 schanz screws were stripped.The percutaneous depth gauge, the depth gauge for locking screws, and the depth gauge for cortex screws were bent.It is unknown how the procedure was completed but there was a surgical delay of fifteen (15) minutes.This report involves one (1) 2.0mm drill sleeve 42mm long.This is report 2 of 2 for (b)(4).This product complaint, (b)(4), is related to (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.H6 - codes updated to imdrf codes.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: 2.0MM DRILL SLEEVE 42MM LONG
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11424041
• MDR Text Key: 239470079
• Report Number: 2939274-2021-01214
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982261274
• UDI-Public: (01)10886982261274
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD312.021
• Device Catalogue Number: SD312.021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR LOCKING SCREWS