MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM/1.1MM DOUBLE DRILL SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.14
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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) 2020, that the drill sleeve appeared to be broken after drilling.The surgeon mentioned that the drill sleeve became stuck in the patient¿s bone while he was drilling.The was no reported surgical delay.The procedure was completed successfully.Patient outcome was unknown.Concomitant devices reported: drill bits: trauma (part number unknown, lot unknown, quantity unknown).This report involves one (1) 1.5mm/1.1mm double drill sleeve.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported the surgeon wanted to use a lag screw using the compact hand set.He had already drilled a two (2) millimeter hole near the cortex.He wanted to use the drill sleeve to centralize the hole to drill the far cortex.After drilling, it was noted the tip of drill sleeve looked broken.It was noted it had gotten stuck in the patient¿s bone.The procedure was completed using the other end of the drill sleeve to complete the drilling.
Additional Manufacturer Narrative
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.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.

• Brand Name: 1.5MM/1.1MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10588616
• Report Number: 8030965-2020-07464
• Device Sequence Number: 16849691
• Product Code: FZX
• UDI-Device Identifier: 10886982187604
• UDI-Public: (01)10886982187604
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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 Model Number: 312.14
• Device Catalogue Number: 312.14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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 - DRILL BITS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention