MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 16MM CANNULATED DRILL BIT; TEMPLATE

Model Number 03.037.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during the extended incision, the aiming arm did not properly align with the distal hole of the short tfna nail.The instrumentation was loose.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed.This is report 2 of 8 for (b)(4).

Manufacturer Narrative

Part 03.037.003, lot f-22407: manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: august 31, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 16MM CANNULATED DRILL BIT
• Type of Device: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11337603
• MDR Text Key: 232181740
• Report Number: 2939274-2021-00900
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10886982070197
• UDI-Public: (01)10886982070197
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.003
• Device Catalogue Number: 03.037.003
• Device Lot Number: F-22407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 10MM CANNULATED TAPERED DRILL BIT; 10MM CANNULATED TAPERED DRILL BIT; 130 DEG AIMING ARM; 130 DEG AIMING ARM; 16MM CANNULATED DRILL BIT; COMPLETE RADIOLUCENT INSERTION HANDLE; COMPLETE RADIOLUCENT INSERTION HANDLE
• Patient Outcome(s): Required Intervention