MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE FEMUR ANTEGRADE IMN INSTRUMENTS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-3105

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "it was difficult to remove the drill sleeve that had been inserted into the adjusting device of the distal target device.The lock mechanism was stiff, blood was clogged and the lock was stiff.Please check if there are any defects in the adjusting device itself." additional information: according to the report, the blood was clots and lock mechanism was hard.No medical intervention measures were needed.

Manufacturer Narrative

The reported event, instrument - assembling / disassembling impaired during implantation, was not confirmed.The devices were returned in cleaned condition and could be assembled / disassembled as intended.Function of clamping / releasing feature (for sleeves) and height adjustment was fully given.The sleeves could be inserted and removed easily.No deviations were found during review of the manufacturing and inspection documents (dhr).The returned adjusting device was documented as faultless prior to distribution.The risk management file review showed that the complained event was addressed adequately; no threshold exceedances found.No nc/capa record was filed regarding the item in question with this failure mode.Also, no further events regarding dried blood was reported.With available information no product deficiency was determined.The event was regarded as user related.In case further information becomes available we reserve the right to reopen the investigation and to re-assess the root cause.

Event Description

As reported: "it was difficult to remove the drill sleeve that had been inserted into the adjusting device of the distal target device.The lock mechanism was stiff, blood was clogged and the lock was stiff.Please check if there are any defects in the adjusting device itself." additional information: according to the report, the blood was clots and lock mechanism was hard.No medical intervention measures were needed.

• Brand Name: ADJUSTING DEVICE FEMUR ANTEGRADE IMN INSTRUMENTS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11373086
• MDR Text Key: 233335795
• Report Number: 0009610622-2021-00292
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357035
• UDI-Public: 07613327357035
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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 Model Number: 2353-3105
• Device Catalogue Number: 23533105
• Device Lot Number: KME914877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1