MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME DILATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286750010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during an inspection, a hairline fracture was identified on the instrument.No patient or surgical involvement.This report is for (1) viper prime dilator.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.H3, h6: a product investigation was conducted.Visual inspection: the viper prime dilator (p/n:286750010, lot number:pu126733) was received at us cq.Upon visual inspection, the shaft was observed to be cracked at the distal end.No other issues were identified with the returned device.Dimensional inspection: complaint relevant dimensional inspection cannot be performed due to the geometry of the device and post-manufacturing damage.Investigation conclusion: this complaint could be confirmed as the tip of the device was identified to be cracked.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.A review of the receiving inspection (ri) for viper prime dilator was conducted identifying that lot number pu126733 was released in a single batch.Batch1: lot qty of (b)(4) units were released on (b)(4)2018 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 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: VIPER PRIME DILATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12032095
• Report Number: 1526439-2021-01257
• Device Sequence Number: 14491806
• Product Code: LXH
• UDI-Device Identifier: 10705034507569
• UDI-Public: (01)10705034507569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 286750010
• Device Catalogue Number: 286750010
• Device Lot Number: PU126733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1