MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS; EXTRACTOR

Catalog Number	309.039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was received, and the product evaluation is in progress.No conclusion can be drawn.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 during a hardware removal due to wound infection, it was noted that the extraction bolt was broken.Initially, in 2009, the patient had distal tibial plate implantation.During the procedure, three (3) unknown locking screws on the proximal side could not be extracted easily.The surgeon cut the unknown locking screws by the carbide drill bit and removed the unknown plate.The surgeon was able to remove the two (2) unknown screws successfully using the hollow reamer and the extraction bolt.However, while the surgeon was trying to remove the most proximal unknown locking screw, the extraction bolt broke off.The surgeon drilled until the contralateral bone by the hollow reamer and extracted the unknown locking screw using a needle-nose plier.As per surgeon, the three (3) unknown locking screws should be fixed bi-cortically, but they scarcely penetrated the contralateral bone.So, that induced porosis on self tap part of the unknown locking screw and made it difficult to remove the screws easily.The procedure was completed with a surgical delay of one (1) hour.The anesthetic time was prolonged from an hour to three (3) hours and the normal removal time is one (1) hour.The surgeon confirmed visually during the operation and confirmed by x-ray was taken on an unknown date after the procedure that there was no fragment left in the patient's body.The surgeon also confirmed that there was no problem after checking the broken devices.However, there is concern about the second fracture because the hole was big compared to the screw hole.So, there is a possibility of a second fracture because the hole was big.And as confirmed by the reporter, there had not been a second fracture.Patient and procedure outcome were unknown.(b)(4) captures intra-operative event while (b)(4) captures the post-operative event.Concomitant device : unknown proximal tibia plate ( part unknown, lot unknown, quantity 1) and unknown locking screws ( part unknown, lot unknown, quantity 3).This report is for one (1) extraction bolt.This is report 1 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.The tip of the extraction bolt is broken as complained.The broken off part was not returned for evaluation.Besides, the instrument presents signs of use.The relevant dimensions cannot be verified due to the damage incurred.The complaint condition is confirmed as the tip is broken.This production lot (2184005) was manufactured in april 2006 according to the specification.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.Considering that this device is more than ten years old the damage appears to be the result of repeated use and high applied force during use.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 309.039, lot: 2184005, manufacturing site: bettlach, release to warehouse date: 01.April 2006.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.
Event or Problem Description
Updated event description: concomitant device reported: unknown proximal tibia plate (part # unknown, lot # unknown, quantity 1).
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: EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8636579
• Report Number: 8030965-2019-64426
• Device Sequence Number: 16605683
• Product Code: HWB
• UDI-Device Identifier: 07611819056503
• UDI-Public: (01)07611819056503
• 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): 04/25/2019

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: 309.039
• Device Lot Number: 2184005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 07/08/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/05/2019; 07/16/2019
• 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 - PLATES: PROXIMAL TIBIA PLATE; UNK - PLATES: PROXIMAL TIBIA PLATE; UNK - PLATES: PROXIMAL TIBIA PLATE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - PLATES: PROXIMAL TIBIA PLATE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72