MAUDE Adverse Event Report: SYNTHES MONUMENT 6.5MM CANNULATED SCREW 32MM THREAD 95MM; SCREW, FIXATION, BONE

Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Medwatch: patient identifier, dob & weight not provided for reporting.Not explanted.Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: screws (quantity 2).Screwdriver (quantity 1).No conclusions could be drawn as no devices were returned for manufacturer review or investigation.Additionally, device history record reviews could not be requested as specific part and lot numbers for the associated devices are not invalid.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Customer quality unit received a maude report forwarded from department of human services; this report is against (b)(4).Only additional and/or corrected information will be contained in this report.It was reported that a patient had an elective removal of bilateral deep hip implants on (b)(6) 2016.The original procedure was performed on (b)(6) 2016 in which a periacetabular osteotomy with surgical hip dislocation and greater trochanteric osteotomy was performed for bilateral slipped capital femoral epiphysis.During the removal procedure the surgeon was unable to remove the 6.5 mm cannulated screw on the right hip due to the screw being stripped; bony growth was noted around the screw head.The surgeon used a reverse cutting screw removal, then the screwdriver broke and the tip of the screwdriver was confirmed via fluoroscopy to remain in the head of the screw and not free in the muscle mass.The surgeon reviewed the options with the patient¿s mother and they elected to not attempt further removal of the screw.During the removal on the left hip, two screws were easily and successfully removed without complications.It is unknown if there was a surgical delay.The patient was wheeled from the operating theater in stable condition.This complaint involves one device.Concomitant devices reported: screws (quantity 2).Screwdriver (quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.5MM CANNULATED SCREW 32MM THREAD 95MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6522521
• Report Number: 1719045-2017-10348
• Device Sequence Number: 11432
• Product Code: HWC
• UDI-Device Identifier: 10886982149466
• UDI-Public: (01)10886982149466(10)1028436
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/03/2017
• Patient Sequence Number: 1