MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 28MM; SCREW, FIXATION, BONE

Catalog Number	04.211.028TS
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
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.D2b: additional device product codes: hrs.E1: initial reporter facility name: (b)(6).H3, h4, h6: 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 history review (dhr): sterile part: 04.211.028ts.Sterile lot no:9l20160.Release to warehouse date: 23 mar, 2022.Expiry date: 01 mar, 2027.Manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.211.028.Non-sterile lot: 468p822.Manufacturing site: werk selzach.Release to warehouse date: 05 nov, 2021.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6), 2023, the patient underwent open reduction/internal fixation surgery for a humeral fracture with the locking screw and plate.During screw insertion, the screws didn¿t lock to the plate in two holes (second and sixth holes from the distal hole).The surgeon used a drill guide and drill, and inserted the screws after measuring.That time, two screws were idle, and the surgeon re-drilled and re-inserted the screws.The reinserted screws were locked to the plate.The surgery was completed successfully within a 30-minute delay.The patient status/outcome was reported to be stable.This report involves one 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 28mm.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 28MM
• 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 19380 ; 3035526892
• MDR Report Key: 17720242
• Report Number: 8030965-2023-11348
• Device Sequence Number: 7278846
• Product Code: HWC
• UDI-Device Identifier: 10886982119063
• UDI-Public: (01)10886982119063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 04.211.028TS
• Device Lot Number: 9L20160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - PLATES: TRAUMA; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN
• Patient Sex: Unknown