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

Model Number	2199-2022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
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
Primary total hip replacement (exeter/trident) completed.Primary revised due to stability.Liner exchanged from trident 36d 0dg liner to trident 22.2d constrained liner using 22.2mm constrained impactor.During the revision case, part of the constrained liner impactor flange broke.Following the case, an replacement was lodged to replace the instrument.Later theatre staff emailed a booking request for "debridement of seroma, exeter dair backup" for the aforementioned patient.The seroma debridement proceeded.Theatre staff alerted stryker personnel that during the seroma debridement, a piece of plastic debris was removed from the patients hip, alleged to have arisen from the constrained liner impactor used and broken during the previous case.This is for the "debridement of seroma".

• Brand Name: CONSTRAINED 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: 14982980
• Report Number: 0002249697-2022-00995
• Device Sequence Number: 5728464
• Product Code: HWC
• UDI-Device Identifier: 07613327244861
• UDI-Public: 07613327244861
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2199-2022
• Device Catalogue Number: 2199-2022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown