MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TAP FOR 3.5MM CANCELLOUS BONE SCREWS/50MM CALIBRATION; TAP, BONE

Model Number	311.349
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is company representative.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
Device report from synthes reports an event in (b)(6) as follows: it was reported a tap for a bone screw snapped and broke intraoperatively while in use, during an unknown procedure on (b)(6) 2020.The surgeon was easily able to remove the device from the patient.Additionally, the surgeon reported screws loosening when inserting screws and noted that two locking caps cross threaded upon insertion.The screws were then replaced with two more.The procedure was completed sucessfully with no surgical delay.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This is report 1 of 4 for (b)(4).
Event or Problem Description
While inserting all 4 screws, the surgeon felt that they were loosening.Once inserted, the screws were secure and the procedure was continued.
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.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: TAP FOR 3.5MM CANCELLOUS BONE SCREWS/50MM CALIBRATION
• Common Device Name: TAP, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10206698
• Report Number: 8030965-2020-04517
• Device Sequence Number: 19486231
• Product Code: HWX
• UDI-Device Identifier: 10705034768670
• UDI-Public: (01)10705034768670
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 311.349
• Device Catalogue Number: 311.349
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NUTS; UNK - SCREWDRIVERS; UNK - SCREWS; UNK - NUTS; UNK - SCREWDRIVERS; UNK - SCREWS