MAUDE Adverse Event Report: SYNTHES GMBH HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS

Model Number	309.480
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
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.Patient information: device used in a veterinary case - no patient information will be reported.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that reamers was found broken in two fragments , the broken fragments are visible in photos.No others problems were reported.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for reamers.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 on that on (b)(6) 2022, the surgeon was using a screw removal set that is owned by the animal health team.The surgeon broke the base of one of the hollow reamers.The failure was through the hole in the threaded base / drill attachment and not the hollow reamer tube itself.The surgeon believed that the failure happened as the surgeon had to ream quite far along the screw.After reaming to this depth, the screw backed out with the extraction bolt quite easily and the case was completed.This report involves one (1) spare reamer tube for hollow reamer (309.450).This is report 1 of 1 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 h3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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.H6: photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that hollow reamer-complete for 4.5mm screws was found broken in two fragments, the broken fragments are visible in photos.No others problems were reported.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that hollow reamer-complete for 4.5mm screws\, was broken at the shaft.The broken piece was returned.No other issues was found a functional test could not be performed as the mating device was not returned.A dimensional inspection was unable to be performed for the hollow reamer-complete for 4.5mm screws, due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the hollow reamer-complete for 4.5mm screws, would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 309.450, lot no: 9746625, release to warehouse date: 14 jan 2016, manufacturing site: werk bettlach.A manufacturing record evaluation was performed for the finished article lot 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
This report is for one (1) hollow reamer-complete for 4.5mm screws.

• Brand Name: HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CHE ; SZ CHE
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15319546
• Report Number: 8030965-2022-06113
• Device Sequence Number: 5206300
• Product Code: HTO
• UDI-Device Identifier: 10886982185730
• UDI-Public: (01)10886982185730
• 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,Followup,Followup

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 Model Number: 309.480
• Device Catalogue Number: 309.450
• Device Lot Number: 9746625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 09/28/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/24/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2016
• 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: HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS; SPARE REAM TUBE HOLLOW REAM (309.450); UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Sex: Unknown