MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8.0MM/3.2MM DRILL SLEEVE 200MM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.064
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(6) as follows: it was reported that on (b)(6) 2019, open reduction internal fixation surgery for the proximal humeral fracture was performed with an unknown multiloc humeral nail (mhn).During distal locking, when the surgeon drilled one of the hole distal hole which was more proximal, the drill bit interfered with an unknown proximal screw.The surgeon drilled and inserted an unknown screw into the most distal hole first.Then, the surgeon checked the position of the instruments by x-rays and found the unknown drill pointed a rather posterior direction while using the aiming arm.Thus, the surgeon adjusted the drill sleeve and could drill without interference.The surgery was completed successfully without surgical delay.There was no adverse consequence to the patient.Concomitant device reported: unknown multiloc humeral nail (part #: unknown, lot #: unknown, quantity: 1) and unknown distal locking screw (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) 8.0mm/3.2mm drill sleeve 200mm.This is report 4 of 5 for (b)(4).

• Brand Name: 8.0MM/3.2MM DRILL SLEEVE 200MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8703511
• Report Number: 8030965-2019-65355
• Device Sequence Number: 11329761
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/17/2019
• 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 - NAILS: MULTILOC HUMERAL; UNK - SCREWS: NAIL DISTAL LOCKING