MAUDE Adverse Event Report: STRYKER GMBH REPOSITIONING FORCEPS SPS L143MM; REDUCTION FORCEPS

Catalog Number	702932
Medical Device Problem Codes	Break (1069); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tooth of the scissors were broken off.It is unknown when did the issue occur.There were no reports of surgical delays or patient harm.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to h6 (device & method) codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, it was communicated during the communications that the device broke, but the problem was not caused by the item.Due to the long period of time the device was used, the device broke.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the tooth of the scissors were broken off.It is unknown when did the issue occur.There were no reports of surgical delays or patient harm.New information from rep: the sales representative clarified that the initial request was opened by the customer in error.The customer intended to request a replacement due to normal wear and tear, which resulted from high usage of the product, and not to submit a product complaint.The customer¿s request was related to a routine need for replacement, not any defect or malfunction of the product.

• Brand Name: REPOSITIONING FORCEPS SPS L143MM
• Common Device Name: REDUCTION FORCEPS
• 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: 20024615
• Report Number: 0008031020-2024-00329
• Device Sequence Number: 15621968
• Product Code: LXH
• UDI-Device Identifier: 04546540414182
• UDI-Public: 04546540414182
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 702932
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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