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

Model Number	2353-3105
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2021-00292
• Device Sequence Number: 11698068
• Product Code: HSB
• UDI-Device Identifier: 07613327357035
• UDI-Public: 07613327357035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1