MAUDE Adverse Event Report: SYNTHES GMBH SPIKED ROUND DISK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.100.120
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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 was 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.
Event or Problem Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2021 during an acetabular reconstruction procedure, the ball spike pusher was used, with a round spiked disc.When the ball spike was withdrawn, it became disconnected from the disc, which remained in the patient.Attempts were made for sixty (60) minutes to retrieve the disc, after which a clinical decision was made to leave it in situ.This report involves one (1) spiked round disk.This is report 1 of 2 for (b)(4).

• Brand Name: SPIKED ROUND DISK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11778540
• Report Number: 8030965-2021-03586
• Device Sequence Number: 3437542
• Product Code: LXH
• UDI-Device Identifier: 07611819302389
• UDI-Public: (01)07611819302389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: Health Professional
• Device Catalogue Number: 03.100.120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES; UNK - SCREWS: TRAUMA; UNKNOWN BALL SPIKE PUSHER
• Outcome Attributed to Adverse Event: Required Intervention