MAUDE Adverse Event Report: SYNTHES GMBH 8.0MM/3.2MM DRILL SLEEVE 200MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.064
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.D4: udi: as the lot and serial number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: 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.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on june 28, 2024, the patient underwent orif surgery for fracture of the proximal humerus on proximal humerus with the products in question.In the surgery, during the drilling of the distal lateral stop, the drill bits in question were not sharp enough, although the patient's bone quality was also a factor.The sleeve in question was inserted and drilled until it contacted the bone, avoiding the soft tissue, but the drill interfered in the g-hole.The image confirmed that the drill tip reached inside the nail hole, so when the drill tip was lightly tapped with a hammer, the drill tip passed through the hole.Finally, when inserting the end cap in question, the end cap was reinserted several times, but it did not engage properly, and the surgeon decided to close the wound with the cap engaged at an angle.The surgery was completed successfully with a 30 minute surgical delay.No further information is available at this time.This report is for one (1) 8.0mm/3.2mm drill sleeve 200mm.This is report 5 of 6 for complaint (b)(4).

• Brand Name: 8.0MM/3.2MM DRILL SLEEVE 200MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19810758
• Report Number: 8030965-2024-09132
• Device Sequence Number: 18229914
• Product Code: LXH
• UDI-Device Identifier: 07611819760912
• UDI-Public: (01)07611819760912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 03.010.064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.2 3-FLTD DRILL BIT QC/330/100 CALIB; DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/QUIC; MULTILOC END CAP F/MULTILOC HN/PHN EXTEN; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 84 KG