MAUDE Adverse Event Report: STRYKER GMBH WIRE TENSIONER HOFFMANN LRF; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	49339100
Medical Device Problem Codes	Break (1069); Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: " during the cleaning and sterilization , instrument has been broken.Do not know what happened, but parts do not fit like they have done before.They have used cleaning protocol advice we have in writing (ifu).No harm in operation when used, only in cleaning process have noticed broken device.No patient harm or delay.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to section h6 (results code).The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the received product only have some dents and scratches at the black handle.Otherwise there are no visible damage are shown.Mechanical engineering reviewed the received information and noted: during the investigation could be determined that the adjusting ring with which the tensile force is set and locked with "loctite" is loose.This leads to the fact that the setted, calibrated, and tested force no longer corresponds to the markings.In a further investigation, the adjustment ring was loosened, it was found that no adhesive residue (loctite) was visible.This suggests that the ring was probably assembled incorrectly with less or without loctite.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: " during the cleaning and sterilization , instrument has been broken.Do not know what happened, but parts do not fit like they have done before.They have used cleaning protocol advice we have in writing (ifu).No harm in operation when used, only in cleaning process have noticed broken device.No patient harm or delay.".

• Brand Name: WIRE TENSIONER HOFFMANN LRF
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19067470
• Report Number: 0008031020-2024-00152
• Device Sequence Number: 17609920
• Product Code: LXH
• UDI-Device Identifier: 07613252611035
• UDI-Public: 07613252611035
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 49339100
• Device Lot Number: J43995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2016
• 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