MAUDE Adverse Event Report: SYNTHES GMBH 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP - STERILE; REAMER

Catalog Number	351.76S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgeon removed a tibial nail on (b)(6) 2023 because of a possible infection.The nail was difficult to remove for various reasons.The surgeon was unable to connect the appropriate extractor for the ex locking nails, and therefore had to try multiple options such as the non-synthes set, jamming two reaming rods, a non-synthes extraction hook, and a non-synthes conical extractor, which successfully extracted the nail.The non-synthes extraction hook tip broke off distally to the nail.There were already previous unknown fragments as well from when the surgeon was attempting to remove a difficult interlocking screw.The most distal screw was buried in bone and eventually was knocked out successfully.Additionally, one of the wrappers of a 3.0 reaming rod split.The surgery was completed successfully with a delay of 45 minutes.It is not known whether the fragments were removed from the tibia.After the surgery, it was noted in the sterile processing department that the extraction screw threads have been damaged.This report involves one 3.0mm reaming rod/950mm w/straight ball tip - sterile.This report is related to (b)(4), which reports the possible infection.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history review (dhr): part number: 351.76s-us lot number: 812p532 part manufacture date: 29-aug-2022 manufacturing location: elmira part expiration date: 31-jul-2031 nonconformance noted: n/a dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.0mm reaming rod/950mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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: 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP - STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17848295
• Report Number: 8030965-2023-12397
• Device Sequence Number: 19911598
• Product Code: HTO
• UDI-Device Identifier: 10886982193971
• UDI-Public: (01)10886982193971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Device Catalogue Number: 351.76S
• Device Lot Number: 812P532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACTION SCR FOR TI FEM & TIB NAIL
• Patient Age: 32 YR
• Patient Sex: Unknown
• Patient Weight: 94 KG