MAUDE Adverse Event Report: GRENCHEN SYNTHES PRODUKTIONS GMBH 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 18; SCREW, FIXATION, BONE

Model Number	02.211.018
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional pro-code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Device not available - discarded.Initial reporter is j&j company representative.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 an unknown date, screw heads were stripped out and would not retain the screwdriver and thus not allowing them to be inserted.It is unknown if there is surgical delay reported and if the procedure was successfully completed.This complaint involves two (2) devices.This report is for one (1) 2.7 va lckng scr slf-tpng t8 sd rec 18.This report is 2 of 2 for pc-(b)(4).
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.Updated data: b5, section e.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
The issue was discovered during the procedure.

• Brand Name: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 18
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): GRENCHEN SYNTHES PRODUKTIONS GMBH; solothurnerstrasse 186; grenchen 2540 ; SZ 2540
• MDR Report Key: 12094165
• Report Number: 3009450884-2021-00002
• Device Sequence Number: 11811989
• Product Code: HWC
• UDI-Device Identifier: 10886982053602
• UDI-Public: (01)10886982053602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: No Information
• Device Model Number: 02.211.018
• Device Catalogue Number: 02.211.018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 18.; UNK SCREWDRIVER.