MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Catalog Number	04.211.016S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procode: hrs.D10: date of concomitant therapy is 14-july-2022.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part:04.211.016s.Lot:9l17848.Manufacturing site: werk selzach.Supplier:früh verpackungstechnik ag release to warehouse date:16 mar 2022.Expiration date: 01 mar 2032.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.016.Non-sterile lot # 648p105.Manufacturing site: werk selzach.Supplier: synthes usa hq, inc.Release to warehouse date:07 feb 2022.Product was not returned.Based on the information available, it has been determined that no corrective and 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 japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent an unknown surgery with the products in question.On an unknown date, the olecranon implants were removed as bone fusion was achieved.During the procedure, it was found that two of the screws were difficult to remove.One of the screws broke immediately upon turning the screw.The other screw broke when the entire plate was being turned while attempting to remove the screw.Patient outcome is stable.No further information is available.This report is for a 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 16mm.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17718725
• Report Number: 8030965-2023-11301
• Device Sequence Number: 7289070
• Product Code: HWC
• UDI-Device Identifier: 10886982119001
• UDI-Public: (01)10886982119001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 04.211.016S
• Device Lot Number: 9L17848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L22 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L22 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L28 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L36 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L44 TA; VA-LCP OLECR PL 2.7/3.5 LE 4HO L116 TAN
• Patient Sex: Unknown