MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LOCKING SCREW; IMPLANT

Catalog Number	UNK_KIE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remained inside the patient.
Event or Problem Description
After the primary surgery in (b)(6) 2018, the screw was going to be removed on (b)(6) 2019.At the time of removal of the screw, the surgeon forgot to take out the end cap on screw.Therefore, the screw was overloaded and broke during removal.Since there was no instrument for broken screw, it was closed as it was.The revision surgery will be rescheduled.
Additional Manufacturer Narrative
Correction to section d.
Event or Problem Description
After the primary surgery in (b)(6) 2018, the screw was going to be removed on (b)(6) 2019.At the time of removal of the screw, the surgeon forgot to take out the end cap on screw.Therefore, the screw was overloaded and broke during removal.Since there was no instrument for broken screw, it was closed as it was.The revision surgery will be rescheduled.

• Brand Name: UNKNOWN LOCKING SCREW
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9341337
• Report Number: 0009610622-2019-00929
• Device Sequence Number: 11472296
• Product Code: HSB
• UDI-Device Identifier: 04546540515421
• UDI-Public: 04546540515421
• Combination Product (Y/N): N
• PMA/510(K) Number: K042396
• 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): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65