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	Insufficient Information (4580)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was doing a suprapatellar tibial nail for a patient with a mid shaft tibial fracture.Surgery was going as planned, until nail insertion through the sleeve.The metal portion of suprapatellar sleeve became disengaged from the silicone portion as the nail was going in.The metal portion of suprapatellar sleeve went down into the tibial bone around the proximal portion of the nail.Surgeon had to remove nail and sleeve from patient to get the metal piece out of patient¿s bone.There was concern about damage to patient¿s cartilage from the metal piece sticking outside of the silicone.A new sleeve was opened, and procedure was resumed without further incident.A surgical delay of about 10 minutes occurred for carefully removing sleeve.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11.Additional manufacturer narrative: a1: (b)(6).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.E1.Initial reporter facility name: (b)(6).H3, h6: part: 03.043.033s.Lot no: 10351999.Manufacturing date: 30 june, 2023.Expiration date: 29 feb, 2028.Manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was not returned to depuy synthes; however, photos and x-ray were provided for review.The photo and x-ray investigation revealed the device was observed with the inner sleeve and one prong deformed.The second prong was also noted with a fragment broken.Broken fragment was note observed on images provided.The observed condition of the device could be consistent with a component failure that was caused by exposure to unintended forces; however, a complete potential cause could not be determined.Properly handling and attention to the approved use of the device diminishes the risk of failure.Surgical technique (b)(4) rev.Af was reviewed, and the following relevant statement was found: assemble the trocar to the protection sleeve.Insert the assembly through the incision into the knee joint, so that it glides between the articular surface of the patella and the trochlea of the distal femur and rests securely in this groove, while the patella is displaced anteriorly above the sleeve.Allow the trocar to slide out, as the protection sleeve is advanced to the anterior surface of the proximal tibia.Unlock the trocar by rotating it a quarter turn and remove it from the sleeve.Insert the wire guide into the protection sleeve and advance it to the anterior surface of the proximal tibia.Insert a guide wire approximately 8 cm¿10 cm and check the position under imaging in the ap and lateral views.Precaution: flexion of the knee must not be changed once the guide wire is inserted.A change could lead to increased pressure on the cartilage and could hinder surgical steps.Adjustments to the guide wire location can be ¿dialed-in¿ by rotating the wire guide to place a second guide wire while the first guide wire remains in place.After correct placement of the second guide wire, remove the initial, central guide wire.Take out the wire guide and re-insert it over the correctly placed guide wire through its central hole, to ensure that the instruments are centered over the correct entry point.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the protec slv/ flex/ lg for nl 8-11 / -s would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50771014
• Report Number: 8030965-2026-09316
• Device Sequence Number: 21204271
• Product Code: LXH
• UDI-Device Identifier: 10886982298850
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 03.043.033S
• Device Lot Number: 10351999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 14 YR
• Patient Sex: Male