MAUDE Adverse Event Report: SYNTHES MONUMENT CONICAL EXTRACTION DEVICE FOR THREADED WASHERS; SCREWDRIVERS

Catalog Number	309.501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Device history records review was completed for part# 309.501, lot# 7637974.Supplier: (b)(4)., release to warehouse date: (b)(6) 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
It was reported that a patient underwent an arthroscopy procedure on (b)(6) 2017 for the attempted hardware removal of a synthes locking lateral proximal tibial plate and six (6)locking screws.It was reported that the devices were too close to the patient¿s skin and were bothering him.The original surgery was performed approximately ten (10) years ago at another hospital.It was reported that the plate and screws were intact prior to removal.During the surgery, after removing the first screw without any difficulty, the tip of the extraction instrument broke while attempting to remove the second screw that was reported as stripped.The surgeon was able to remove both broken pieces and it was confirmed that there were no other fragments.The surgeon initially tried several different screwdrivers to remove the screw and then switched to the extraction instrument.The exact length of delay in the surgery was unknown.It was reported that once the instrument broke, the surgeon did not take any further action.Therefore, the patient was closed with one plate and five (5) screws.Postoperative plans are for the patient to be seen by another surgeon for the removal of the remaining devices.There were no further issues reported and the patient was stable.(b)(4) captures the reason for the attempted hardware removal.Concomitant device: screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for one (1) conical extraction device for threaded washers.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device.The conical extraction screw was returned and was confirmed to be broken in the threaded section in a spiral fracture pattern.The balance of the device is in good condition.A visual inspection and drawing review were performed as part of this investigation.The complaint condition of the broken conical extraction screw is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The part numbers or part families of the alleged locking screws and tibia plate are unable to be definitively determined therefore further investigation is not possible.The conical extraction screw is included in the screw removal set.The following drawings were reviewed during investigation.Conical extraction device - 309_501.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The returned screw removal part is specifically designed to be able to remove screws which are stuck and require more torque that usual to remove, or screws which are damaged preventing them from being removed as usual.The nature of screw removal can expose the screw removal parts to excessive torques and off axis forces.Additionally the extractor must bite into the screw in order to successfully function.There were no issues during the manufacture of this product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION DEVICE FOR THREADED WASHERS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6289577
• Report Number: 1719045-2017-10065
• Device Sequence Number: 885919
• Product Code: HXX
• UDI-Device Identifier: 10886982185778
• UDI-Public: (01)10886982185778(10)7637974
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 309.501
• Device Lot Number: 7637974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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: UNKNOWN QUANTITY OF UNKNOWN SCREWDRIVERS
• Patient Age: 34 YR
• Patient Weight: 113