MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN_KIE_PRODUCT; INSTRUMENT

Catalog Number UNK_KIE

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

The customer stated that the pin collet was being used with cordless driver and k-wire in a case.During use a broken part of a k-wire, fell out of the pin collet.New information received, indicates that the piece of k-wire was about an inch long.The k-wire part number or lot number is unknown but they do use stryker k-wires.This occurred during a procedure on the humerus but the surgeon advised the piece of k-wire was from another procedure because it was a different diameter than the one he was using at the time.The collet was sterilized before the humerus procedure.

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Manufacturer Narrative

Investigation summary product inquiry stated an unknown k-wire to be the subject product.No further associated products were reported.Referring to the event description ¿a broken part of an unknown k-wire fell out of the pin collet¿.It was further stated that ¿this occurred during a procedure on the humerus but he surgeon advised the piece of k-wire was from another procedure because it was a different diameter than the one he was using at the time.She also advised the collet was sterilized before the humerus procedure¿.Although repeatedly requested, the product will not be returned for evaluation as it was refused by the account¿s risk manager.Thus, a physical examination could not be carried out.Product data (e.G.Catalogue number and lot code) were also not available.A reasonable examination was not possible.X-rays were not taken and an additional medical intervention was deemed not necessary.The surgeon felt it was low risk.However based on the information given, the event reported could not be confirmed.Review of complaint history, capa databases, risk analysis and device history records was not possible as the product data (catalogue # and lot code) were unknown.The file will be closed formally.In case relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Device was never returned.

Event Description

The customer stated that the pin collet was being used with cordless driver and k-wire in a case.During use a broken part of a k-wire, fell out of the pin collet.New information received, indicates that the piece of k-wire was about an inch long.The k-wire part number or lot number is unknown but they do use stryker k-wires.This occurred during a procedure on the humerus but the surgeon advised the piece of k-wire was from another procedure because it was a different diameter than the one he was using at the time.The collet was sterilized before the humerus procedure.

• Brand Name: UNKNOWN_KIE_PRODUCT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4749332
• MDR Text Key: 17328222
• Report Number: 0009610622-2015-00229
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other