MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLOSED TUBE CLIP GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0125
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "there were three gamma nail surgeries that day, and the product in question was used in the first of them.When the product was being prepared for use in the third surgery, a chip was found on the tip.It was not used in the second surgery.The circumstances of the break are unknown; it is possible that it occurred during the first surgery and a fragment is left in the body of the patient, and it may have occurred during the cleaning process after the first surgery.".
Event or Problem Description
As reported: "there were three gamma nail surgeries that day, and the product in question was used in the first of them.When the product was being prepared for use in the third surgery, a chip was found on the tip.It was not used in the second surgery.The circumstances of the break are unknown; it is possible that it occurred during the first surgery and a fragment is left in the body of the patient, and it may have occurred during the cleaning process after the first surgery.".
Additional Manufacturer Narrative
Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed.The device inspection revealed the following: the identification of the returned instrument was confirmed based on the catalog # and the lot # marked.As reported, the tip is broken, the size of the fragment is significant.Such breakage could only have been produced by careless handling of the device.However, based on the analysis of the instrument and the information provided, it was not possible to identify the exact reason of the breakage.It could be a result of excessive force applied during the operation (such as leverage or unintended impaction) or after falling on the floor.The breakage could also have occurred during careless transportation or sterilization, where the instrument could have broken due to impaction with other devices.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by careless handling of the device, during operation or transportation/sterilization.As a reminder, the instructions for use clearly state that: "¿ during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate!" a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: CLOSED TUBE CLIP GAMMA3®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16099086
• Report Number: 0009610622-2023-00004
• Device Sequence Number: 6559189
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: 04546540508003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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 Model Number: 1320-0125
• Device Catalogue Number: 13200125
• Device Lot Number: K0A3F43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown