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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone not available for reporting.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 europe reports an event in (b)(6) as follows: it was reported patient was scheduled and anesthetized for a revision of epoca hardware for unknown reason on (b)(6) 2018.During the procedure it was realized that the orthotist set was the non-sterile set, not the sterile set.As a result, the set was missing the sterile drill bit.Surgery was not completed at that time.The sterile drill bit was ordered and surgery was then completed four (4) days later.This report is for one (1) unknown drill bit.This is report 1 of 1 for (b)(4).

• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; 19380; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7906238
• MDR Text Key: 121617209
• Report Number: 8030965-2018-56625
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention