MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-13MM / STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.404.019S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Initial reporter is synthes sales 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 (b)(6) 2022, the ria 2 system through the advanced tibia nail protection sleeve was used to collect bone harvest to treat a non union tibia shaft fracture.While using the 11mm ria 2 reamer head, upon pulling the reamer head through the protection sleeve it caught on the metal inside of the insertion sleeve thus destroying the sleeve and ria 2 disposable shaft.There was a surgical delay of 20 minutes.This is report 2 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.D1, d2, d4 h5, h6.

• Brand Name: PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-13MM / STERILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14111331
• Report Number: 2939274-2022-01294
• Device Sequence Number: 20219548
• Product Code: LXH
• UDI-Device Identifier: 10886982298867
• UDI-Public: (01)10886982298867
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 03.404.019S
• Device Catalogue Number: 03.043.034S
• Device Lot Number: 82P2250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 09/01/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 08/31/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.5MM REAMER HEAD FOR RIA 2 STERILE; PROTEC SLV/ FLEX/ LG FOR NL 8-13 / -S; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG