MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD CLAMP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704175
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
Rod clamp´s advantageous one-handed locking and unlocking mechanism is jamming temporarily.No surgical delay, no adverse patient consequences.Another instrument was available and used without issues.This complaint involves two (2) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).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.Visual examination of the returned device showed signs of normal wear however no visual defects that would impact device functionality.The clamp and the ratchet of the device were in good shape.The device was functionally tested and no sticking points/hitches along the ratchet were found, thus reported condition of jammed/seized cannot be confirmed.The overall complaint was not confirmed.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The overall complaint was not confirmed as functional testing showed no evidence of jams/sticking points along the ratchet.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during investigation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).

• Brand Name: ROD CLAMP
• 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: 9255545
• Report Number: 1526439-2019-52327
• Device Sequence Number: 3763960
• Product Code: LXH
• UDI-Device Identifier: 10705034467313
• UDI-Public: 10705034467313
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

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 Catalogue Number: 299704175
• Device Lot Number: GM4606201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 11/22/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/19/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1