MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VERSITOMIC STERILE PIN PACK; UNKNOWN

Catalog Number 234-108-200

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The gtin and product code are not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of oem - (b)(4).

Event Description

It was reported that a piece of the device broke and remained in the patient.

Event Description

It was reported that a piece of the device broke and remained in the patient.

Manufacturer Narrative

Product was not received in-house at stryker endoscopy.Tag cannot provide the fully detailed investigation report to stryker as the device was not returned.In the event that the device is returned, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: reamer broke according to tag: since we have not received the device we can suggest several reasons for breakage: 1.The most likely cause is the use of excessive force that can lead to the breakage of the flexible pin.2.Severe bending can result in pin breakage.3.The flexible guide pin may break if the curved section of the pin is exposed to a dry environment while drilling.4.The flexible guide pin fatigues during drilling and is at risk of breakage if used in more than one surgical case.Manufacture date is not known.H3 other text : 81.

• Brand Name: VERSITOMIC STERILE PIN PACK
• Type of Device: UNKNOWN
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12550574
• MDR Text Key: 273991387
• Report Number: 0002936485-2021-00520
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 234-108-200
• Device Lot Number: 19P01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other