MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT

Catalog Number	03.111.600
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	12/27/2019
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.(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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent a surgery with the guiding block and the screw for guiding block.While a plate was set with the guiding block and a cortex screw was inserted into a proximal hole using the quick drill sleeve, the guiding block was unstable.When the screw was turned in the guiding block the screw broke and the guiding block came off.The tip of the screw for guiding block remained into the plate so a longer plate was used instead, and the surgery was completed successfully with less than 30 minutes delay.The additional incision wasn¿t needed to use the longer plate.Concomitant devices: unknown plates (part# unknown, lot# unknown, quantity# 1), quick drill sleeve 2.4 w/scal f/drill bi (part# 03.111.000, lot# unknown, quantity# 1), guiding block f/2-column dist-rad-pl2.4 6 (part# 03.111.600, lot# unknown, quantity# 1), unknown screws: cortex (part# unknown, lot# unknown, quantity# 1).This report is for one guide block for 2 column plate 6 hole head/right.This is report 2 of 2 for (b)(4).
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.H3, h4, h6: upon visual inspection of the complaint device it can be seen that the broken off tip (whole thread) from the screw of the guidingblock sticks in the plate, this thus confirming the complaint description.Furthermore, the instrument has sings (dents, scratches and deformation) all over from often use over the years.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Unfortunately we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place or/and that a screw (screw of the guiding-block) over-tighten could have led to this damage.To prevent such problems, it is necessary to operate according to the technique guide (036.000.578).The cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 03.111.600, lot: 10-6686, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 28.Feb.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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: GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9612577
• Report Number: 8030965-2020-00519
• Device Sequence Number: 18958496
• Product Code: FZX
• UDI-Device Identifier: 07611819352520
• UDI-Public: (01)07611819352520
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2019

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: 03.111.600
• Device Lot Number: 10-6686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 02/09/2020; 03/04/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/25/2020; 03/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUICK DRILL SLEEVE 2.4 W/SCAL F/DRILL BI; UNK - PLATES; UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR