MAUDE Adverse Event Report: SYNTHES GMBH PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.043.033S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the metal inner metal piece from product protection sleeve for tna came apart and as a result was enclosed around the proximal portion of the tibial nail.There was 45-60 min surgical delay.The instruments were used to remove the metal inner part around the nail.Most of fragments were removed; however, part of the inner metal sleeve that was enclosed below the bone surface was left.Procedure was successfully completed.Patient outcome was unknown.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: h3, 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): part# 03.043.033s.Lot # 10327939.Manufacturing site: werk selzach logistik.Supplier : synthes gmbh.Release to warehouse date: 28 feb 2023.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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
Additional information received states that: a.Please provide patient status/ outcome: patient outcome: pt surgery successful, part of the inner metal sleeve in buried below bone surface but no potential issues are expected at this time.

• Brand Name: PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20333448
• Report Number: 8030965-2024-12284
• Device Sequence Number: 9727936
• Product Code: LXH
• UDI-Device Identifier: 10886982298850
• UDI-Public: (01)10886982298850(17)270731(10)10327939
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.043.033S
• Device Lot Number: 10327939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male