MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INLINE CORACOID DRILL GUIDE; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number 288200

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 10/30/2019

Event Type  malfunction  

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)(6).(b)(4).The lot number is unknown.

Event Description

It was reported by the affiliate via email that during an arthroscopic when inserting the inline coracoid drill guide the jagged edge that is designed to grip into the caracoid bone is the one usually getting clogged with soft tissue, as it occurred during this procedure.No patient consequence.The surgeon had to stop to free the edge of the tissue and that caused a short delay.No additional information was provided.Additional information provided by the affiliate reported a minor surgical delay caused by having to remove the soft tissue from the end of the instrument.The affiliate also reported the case was completed but could not provide additional details but did state surgical intervention was not required.It was also reported specific lot numbers could not be provided.The affiliate later reported this was not a complaint about a specific instrument but a comment about the design on the instrument in general.The surgeon has used the instrument from various depuy kits and this is a comment about the coracoid drill guide design in general.The affiliate reported the device is not available for evaluation.

Manufacturer Narrative

Product complaint # (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.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 : the complaint device is not being returned, it's retained by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.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.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Udi: (b)(4).The lot number is unknown.

• Brand Name: INLINE CORACOID DRILL GUIDE
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9372491
• MDR Text Key: 208198557
• Report Number: 1221934-2019-59769
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705026784
• UDI-Public: 10886705026784
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 288200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/09/2019
• Patient Sequence Number: 1