MAUDE Adverse Event Report: STRYKER GMBH REDUCTION SPOON T2 Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060125
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, on friday,31-may-2024, the surgeon from the arrixaca hospital proceeds to perform tibia fracture surgery with a t2 tibia intramedullary nail.When inserting the fracture reduction piece, it breaks, leaving part of it inside the patient's canal.Given the impossibility of extracting it with the material they had, they completed the surgery, postponing it to wednesday, (b)(6) 2024, to proceed with the extraction of the broken material and the introduction of an intramedullary nail.On wednesday the surgery was performed satisfactorily, being able to extract the broken piece with the material sent for the occasion (stryker difficult extraction kit).
Event or Problem Description
It was reported that, on (b)(6) 2024, the surgeon from the (b)(6) hospital proceeds to perform tibia fracture surgery with a t2 tibia intramedullary nail.When inserting the fracture reduction piece, it breaks, leaving part of it inside the patient's canal.Given the impossibility of extracting it with the material they had, they completed the surgery, postponing it to on (b)(6) 2024, to proceed with the extraction of the broken material and the introduction of an intramedullary nail.On wednesday the surgery was performed satisfactorily, being able to extract the broken piece with the material sent for the occasion (stryker difficult extraction kit).
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned in broken condition.The device inspection revealed the following: the thread had broken in its 1st winding at the rod.The breakage surface identified a brittle fracture.The broken off part was stuck in the returned reduction spoon.The broken fragments could not be put flush together so that both edges did not touch each other.This indicated that the broken threaded fragment was not deep enough ¿ resp.Had not been inserted sufficiently.Both units showed traces of frequent use.Due to the breakage no function was given.A dimensional inspection revealed the dimension being in spec where undamaged.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.In the case presented it was reported that, on (b)(6) 2024, a surgeon from the (b)(6) hospital proceeds to perform tibia fracture surgery with a t2 tibia intramedullary nail.When inserting the fracture reduction piece, it breaks, leaving part of it inside the patient's canal.Given the impossibility of extracting it with the material they had, they completed the surgery, postponing it to on (b)(6) 2024, to proceed with the extraction of the broken material and the introduction of an intramedullary nail.On wednesday the surgery was performed satisfactorily, being able to extract the broken piece with the material sent for the occasion (stryker difficult extraction kit).The fact that the 2 components could not be put flush together identified the universal rod had not been inserted deep enough before use.Having a gap and applying required forces will inevitably lead to material breakage.Based on investigation, the root cause was attributed to a user related issue.Based on available information a deficiency of the device was not verified.

• Brand Name: REDUCTION SPOON T2 Ø9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19728626
• Report Number: 0009610622-2024-00704
• Device Sequence Number: 8327982
• Product Code: LXH
• UDI-Device Identifier: 04546540196040
• UDI-Public: 04546540196040
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 18060125
• Device Lot Number: K578836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown