MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.055
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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) 2020, a spiral blade inserter would not pass through spiral blade aiming arm.Procedure outcome was successful.There was a surgical delay of 1-2 minutes.Patient status was unknown.Concomitant devices reported: spiral blade inserter for ti humeral nails (part 358.696, lot unknown, quantity 1).This report involves one spiral blade aiming arm for ti cannulated humeral nails-ex this is report 2 of 2 for (b)(4).
Event or Problem Description
Customer retaining the product.
Additional 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.D10: complainant part is not expected to be returned for manufacturer review/investigation.D11: concomitant product updated.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: SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX
• 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: 9898047
• Report Number: 2939274-2020-01597
• Device Sequence Number: 2818468
• Product Code: LXH
• UDI-Device Identifier: 10886982067272
• UDI-Public: (01)10886982067272
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 03.010.055
• Device Catalogue Number: 03.010.055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: SPIRAL BLADE AIMING ARM; SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS; SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS; SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS
• Patient Age: 56 YR