MAUDE Adverse Event Report: SYNTHES GMBH PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.043.033S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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: b3: only event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 an unknown date, the surgeon was doing a suprapatellar tibial nail using the tna.After distal locking the nail he went to do proximal locking through the aiming arm.The drill bit was hitting the nail and not targeted correctly.He had to manipulate the leg and try several times to get the drill bit to pass through the nail.After achieving final fixation and removing the nail, the metal sleeve inside protection sleeve came apart from the plastic outer sleeve and remained in the joint when pulling out the device.The surgeon had to aggressively pull on the metal insert to remove it and the edges of the metal sleeve scraped against the patient's articular cartilage.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This report involves one (1) protection sleeve/ flex/ long for nails ø 8-11mm / sterile.This is report 1 of 4 for (b)(4).

• Brand Name: PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 17491879
• Report Number: 8030965-2023-10069
• Device Sequence Number: 12733054
• Product Code: LXH
• UDI-Device Identifier: 10886982298850
• UDI-Public: 10886982298850
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.043.033S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS: TIBIAL; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown