MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONST LINER INSERTER IMPACTOR TIP 22MM; SCREW, FIXATION, BONE

Catalog Number	2199-2022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery the item fractured.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During surgery the item fractured.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: the device was returned in a used condition.The device was returned fractured.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have no been other similar events for the lot referenced.Conclusions: it was reported that the trial broke.The device was returned in a used condition.The device was returned fractured.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CONST LINER INSERTER IMPACTOR TIP 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou 21502 1; CH 215021
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20328449
• Report Number: 0002249697-2024-01337
• Device Sequence Number: 7678539
• Product Code: HWC
• UDI-Device Identifier: 07613327244861
• UDI-Public: 07613327244861
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 2199-2022
• Device Lot Number: SS1861KN
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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: Other
• Patient Sex: Unknown