MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-8MM SHEATH TRIAL; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	254650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via phone that during an unknown procedure the biointrafix sheathtrial 9mm *ea was broken and the biointrafix 7-8mm sheath trial was on break.No patient consequence and no surgical delay was reported.No additional information was provided.Additional information reported by the affiliate stated the hospital disposed of the instruments and they will not be returning for evaluation.It was also reported the service team has reviewed all the items in the kits and noted when pulling on both sides of the instruments, the parts are not loose, neither are there any cracks on the welding point.However, they reported it was noticed that for most of these items there is no lot number visible.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, have received vbk's sets and bio intrafix trail 9 mm is broken and 7-8mm is on break.The complaint device was received and evaluated.The visual inspection reveals that the device was in worn condition and indicate possible heavy use.The shaft and the t-handle were slightly separated, but the device was still in one piece.Because of the condition of the device received and the photo provided by the affiliate, we can confirm the complaint.The device appears to be old; thus, possible root cause for this failure can be attributed to normal field wear since this device is reusable.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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.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.Investigation summary : according to the information provided, have received vbk's sets and bio intrafix trail 7-8mm is on break.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However a photo was provided.Upon visual inspection of the photo/video, the device was observed that it was still in one but it has a crack near the assembly of t-handle, the picture does not allow more information about the break but a slight crack can be observed, as the complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: BIOINTRAFIX 7-8MM SHEATH TRIAL
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9452360
• Report Number: 1221934-2019-59935
• Device Sequence Number: 2606874
• Product Code: LXH
• UDI-Device Identifier: 10886705013418
• UDI-Public: 10886705013418
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

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: 254650
• Device Catalogue Number: 254650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/12/2020; 06/23/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/13/2020; 06/24/2020
• Patient Sequence Number: 1