MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COMPRESSOR; FORCEPS

Model Number	286740000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that the device is damaged.No additional information available.During manufacturer's investigation of the returned device it was identified that the compressor spring assembly was broken.This device condition was evaluated and determined to be reportable on january 31, 2022.This report is for one (1) viper system compressor.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Reporter is a j&j employee.A product investigation was conducted.Visual inspection: the complaint device compressor (product code: 286740000, lot number: km810960) was returned to (b)(4) for investigation.The compressor spring assembly was broken, particularly one portion of the spring had broken near the screw attaching it to the compressor arm.The broken part was not returned.Document /specification review: based on the date of manufacture, the current and manufactured revision of drawing were reviewed.Dimensional inspection: complaint relevant dimension cannot be measured due to device design.Conclusion: the compressor spring assembly was broken.A definitive root cause was not determined during investigation.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 compressor was conducted identifying that lot number km810960 was released in a single batch.(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.

• Brand Name: COMPRESSOR
• Common Device Name: FORCEPS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13416697
• Report Number: 1526439-2022-00165
• Device Sequence Number: 17316046
• Product Code: HTD
• UDI-Device Identifier: 10705034214733
• UDI-Public: (01)10705034214733
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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 Model Number: 286740000
• Device Catalogue Number: 286740000
• Device Lot Number: KM810960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2014
• 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
• Patient Sex: Unknown