MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE

Catalog Number	03.211.002
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, age, date of birth, and weight not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) for a left distal humeral fracture on (b)(6) 2018.During the procedure, the drill guide was not properly fitted to the plate.The surgeon drilled the screw hole and inserted the variable angle (va) locking screw.When the surgeon attempted to remove the screw for replacement, it just spun in the hole and could not be removed.Surgeon cut off the screw head in order to remove the screw.Surgery was completed successfully with a delay of approximately 15 minutes.Patient bled a little due to this event but is reported as stable.Surgeon stated drilling in the incomplete thread engagement may have damaged the screw hole and insertion of the screw at an angle greater than 15 degrees may have damaged the locking mechanism of the plate.Concomitant device reported: plate (part number unknown, lot number unknown, quantity 1) this report is for one (1) 2.0mm universal variable angle locking drill guide.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part no.: 03.211.002.Lot no.: 9506749.Manufacturing location: (b)(4).Release to warehouse date: 17.Jun.2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned devices.Investigation selection.Investigation site: (b)(4).Selected flow: 2.Device interaction/functional.Visual inspection: there are some slight traces of use visible on the va-lcp drill sleeve 2.7 f/drill bit.Otherwise the part is in a good condition.Functional test / dimensional inspection: as the article number of the used plate is unknown we performed a functional test with a demo titanium plate (04.111.690 / lot: l067125) and a stainless steel plate (02.111.690 / lot:l077750) with no difficulties.The received condition of the device does not agree with the complaint description.The complaint cannot be replicated with the returned device.Document/specification review: not required per selected investigation flow as the complaint cannot be replicated.Summary: the received condition of the va-lcp drill sleeve 2.7 f/drill bit does not agree with the complaint description.No failure was detected.The complaint cannot be replicated with the returned device.During the functional test no failure was detected.This lot of (b)(4) pieces was manufactured in june 2015 according to the specification.We are not aware of any other complaint for this article- and lot combination.No additional information regarding used plate was provided.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7437562
• Report Number: 8030965-2018-53175
• Device Sequence Number: 1642652
• Product Code: FZX
• UDI-Device Identifier: 07611819443143
• UDI-Public: (01)07611819443143
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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 Catalogue Number: 03.211.002
• Device Lot Number: 9506749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention