MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG; TEMPLATE

Model Number	03.045.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: without a lot number the device history records review could not be completed.Product was not returned.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.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) 2022, during an unknown procedure, when inserting the proximal static screw, the drill bit was getting caught on the nail posterior to the hole.The screw was finally inserted behind the nail.The proximal dynamic screw was inserted properly with no issues using the long self-retaining power shafts from the ans locking set.There was a surgical delay of twenty (20) minutes.Surgery was completed successfully.No fragments generated.This report is for one (1) drill bit/ calibrated/ 4.2 extra-long this is report 5 of 6 for (b)(4).
Event or Problem Description
This is report 5 of 7 for pc (b)(4).

• Brand Name: DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG
• Common Device Name: 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: 13862191
• Report Number: 2939274-2022-01012
• Device Sequence Number: 14795344
• Product Code: HWT
• UDI-Device Identifier: 10886982292650
• UDI-Public: (01)10886982292650
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 03.045.022
• Device Catalogue Number: 03.045.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145; AIMING ARM/ RADIOLUCENT; INSERTION HANDLE/ RADIOLUCENT LONG; PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S; TIBIAL NAIL-ADVANCED / 10 330 / STERILE; TROCAR / LONG FOR NAILS 8-11 / SILE
• Patient Sex: Unknown