MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP 6.5 CANCELLOUS SCRS 197/150 CALIB; TAP, BONE

Model Number	311.66
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, while using a 6.5mm tap for cancellous bone screws in the ulnar shaft preparing for fixation of an olecranon osteotomy the threaded portion of the 6.5mm tap broke off in the medullary canal of the ulna.The surgeon was unable to retrieve the fragment, it was left in the ulna.The osteotomy was fixed using a plate instead.There was no surgical delay.The procedure successfully completed.The patient outcome is unknown.This report is for a tap.This is report 1 of 1 for (b)(4).

• Brand Name: TAP 6.5 CANCELLOUS SCRS 197/150 CALIB
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12562404
• Report Number: 2939274-2021-05872
• Device Sequence Number: 16429127
• Product Code: HWX
• UDI-Device Identifier: 10886982187505
• UDI-Public: (01)10886982187505
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 311.66
• Device Catalogue Number: 311.66
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Weight: 68