MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM REDUCTION HEAD-ANGLED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	352.055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during a procedure on an unknown date, the tip of the reduction head-angled broke off.The soft tissue bone reduction forceps with ball tips and soft tissue attachment j-shape f/reduction forceps ball and plastic piece broke.The reduction tool/curved with quick coupling wouldn¿t attach to t handle quick coupling (qc); it seemed to be cross threaded.Two (2) 1.8mm coaxial drill guides cross threaded.Two (2) retractor for sciatic nerve were bent.And the tip of the reaming rod push rod broke off.All equipment was used during surgery and had malfunctioned.Surgery was delayed five to 10 (5-10) minutes.There was no patient harm.This report is for a 7.0mm reduction head-angled.This is report 1 of 5 for (b)(4).

• Brand Name: 7.0MM REDUCTION HEAD-ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11261928
• Report Number: 2939274-2021-00602
• Device Sequence Number: 14380404
• Product Code: LXH
• UDI-Device Identifier: 10886982194169
• UDI-Public: (01)10886982194169
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2021

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: 352.055
• Device Catalogue Number: 352.055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1