MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM AND SMALL SCREWS/EXTENDED NOSE; GAUGE, DEPTH

Model Number	SD319.010
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure the drill sleeve top hat broke, retrograde/antegrade femoral nail (rafn) entry reamer is dull, 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, depth gauge for locking screws, and depth gauge for cortex screws were bent.It is unknown how the procedure was completed.There was a surgical delay of fifteen (15) minutes.This report involves one (1) depth gauge for 2.7mm and small screws/extended nose.This is report 8 of 8 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM AND SMALL SCREWS/EXTENDED NOSE
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11413520
• Report Number: 2939274-2021-01169
• Device Sequence Number: 3544751
• Product Code: HTJ
• UDI-Device Identifier: 10886982004987
• UDI-Public: (01)10886982004987
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: SD319.010
• Device Catalogue Number: SD319.010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 13.0MM CANNULATED DRILL BIT 300MM; 2.0MM DRILL SLEEVE 42MM LONG; DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; DEPTH GAUGE FOR LOCKING SCREWS TO 100MM; DRIVE ADAPTOR W/ QC FOR 5.0MM SCHANZ SCR; DRIVE ADAPTOR W/ QC FOR 6.0MM SCHANZ SCR; PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCR