MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM TAB BREAKER, BODY; MISC ORTHO SURGICAL INSTR

Model Number	299704310
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; 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.
Event or Problem Description
It was reported that on (b)(6) 2020, while going through instruments in sterile processing, it was identified that an expedium verse tab was stuck within the tab breaker.A tab breaker end cap as intended to try and dislodge the tab from the breaker but was unsuccessful.The tab remains stuck within the breaker.There was no procedure and patient involvement.This complaint involves three (3) devices.This report is for (1) expedium tab breaker, body.This is report 01 of 02 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.A product investigation was conducted: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as the tab is stuck inside the distal portion of the device.The tab breaker spring is bent inward as well.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for verse 3 in 1 driver, outer shaft was conducted identifying that lot number pu142034 was released in a single batch.Batch1: lot qty of 50 units were released on (b)(6) 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.
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.

• Brand Name: EXPEDIUM TAB BREAKER, BODY
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10323396
• Report Number: 1526439-2020-01407
• Device Sequence Number: 19697406
• Product Code: LXH
• UDI-Device Identifier: 10705034467375
• UDI-Public: 10705034467375
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2020

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: 299704310
• Device Catalogue Number: 299704310
• Device Lot Number: PU142034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/14/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/24/2020
• 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 LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS