MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 52MM; PLATE, FIXATION, BONE

Catalog Number	04.211.052S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional narrative: d2b.: additional pro-code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.Investigation summary: 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.H4, h6: a device history record (dhr) review was conducted: device history lot: part # 04.211.052s, lot # 107l375, manufacturing site: k, release to warehouse date: 15.Nov.2022, expiration date: 01.Nov.2032, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.052, non-sterile lot # 1657p59, manufacturing site: werk selzach logistik, release to warehouse date: 25.Aug.2022, supplier: (b)(4).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) 2023, the patient underwent a revision surgery, which has been reported in (b)(4) (tr202300130).After the revision surgery, a removal surgery was performed on (b)(6) 2024, as bone fusion was achieved.In the removal surgery, the screw in question broke off.The surgeon tried to remove it but gave up removing it because it was difficult to remove and determined to leave it in the patient¿s body.Since (2) screws had been unable to be removed and left in the body in the previous revision surgery, a total of (3 )screws have been left in the body, including the 1st screw that could not be removed.The surgery was completed successfully with 30 minutes delay.No further information is available at this time.This report is for one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 52mm this is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 52MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH LOGISTI; bohackerweg 5; selzach SELZA CH; SZ SELZACH
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19524042
• Report Number: 8030965-2024-07397
• Device Sequence Number: 15588704
• Product Code: HRS
• UDI-Device Identifier: 10886982119186
• UDI-Public: (01)10886982119186
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.211.052S
• Device Lot Number: 107L375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male