MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BITS, DRILL

Device Problem Failure to Align (2522)

Patient Problems Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It is unknown when patient¿s paralysis began.This report is for an unknown drill bit.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, an open reduction internal fixation (orif) with mhn (multiloc humeral nail) short (left) system was applied to proximal humeral fractures.On (b)(6) 2018, it was found that the patient had suffered from neuroparalysis in the radius.The surgeon commented that the drill happened to interfere with the mhn short nail during the surgery.As a remedy, the surgeon used a k-wire to make a preliminary hole followed by another drilling.Concomitant device: multiloc humeral nail (part: unknown, lot: unknown, quantity: 1) this report is for an unknown drill bit.This is report 1 of 1 for (b)(4).

Event Description

It was initially reported that the original procedure was completed on (b)(6) 2018.Further information was received indicating the original procedure occurred on (b)(6) 2018.

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.Additional narrative: event, concomitant medical products: complained device is no longer expected to be returned to the manufacturer for investigation.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.

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.Date of event: drill interfered with nail during procedure performed on (b)(6) 2018; however it is unknown when patient¿s paralysis began.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 Description

Further it was clarified that the original procedure was completed on (b)(6) 2018 (as initially reported on initial medwatch) and not on (b)(6) 2018.

• Type of Device: BITS, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7705900
• MDR Text Key: 114549059
• Report Number: 8030965-2018-55170
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY DATE: JUNE 14, 2018; ., THERAPY DATE: (B)(6) 2018
• Patient Outcome(s): Required Intervention