MAUDE Adverse Event Report: DEPUY MITEK MANIPULATOR GRASPER; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number	214626
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch: 1221934-2017-10126.
Event or Problem Description
Affiliate reported via email during arthroscopic rotator cuff repair, suture anchor became dislodged (from oesteopaenic bone).During attempts by surgeon to remove the loose anchor (arthroscopically), both devices, mentioned above, were damaged and failed to open / close effectively.Need replacing.Alternate device (from competitor tray of shoulder instruments) were used to eventually remove anchor.Approx 2 minute delay.No adverse event to patient.Additional information received via email from the affiliate on 3-3-17: the original bone hole was not used to complete the procedure.The bone hole left unfilled.Surgeon happy with repair with other anchors used.Lot numbers are as follows: ratcheted grasper - (214606) - 16j02; suture manipulator - (214626) - 13e01.Additional information received via email from the affiliate on 3-20-17: no product information had been provided in relation to the anchor.
Additional Manufacturer Narrative
Associated medwatch: 1221934-2017-10126.
Event or Problem Description
Affiliate reported via email during arthroscopic rotator cuff repair, suture anchor became dislodged (from osteopenic bone).During attempts by surgeon to remove the loose anchor (arthroscopically), both devices, mentioned above, were damaged and failed to open / close effectively.Need replacing.Alternate device (from competitor tray of shoulder instruments) were used to eventually remove anchor.Two minutes delay.No adverse event to patient.Additional information received via email from the affiliate on (b)(6) 2017.The original bone hole was not used to complete the procedure.The bone hole left unfilled.Surgeon happy with repair with other anchors used.Lot numbers are as follows: ratcheted grasper - (214606) - 16j02.Suture manipulator - (214626) - 13e01.Additional information received via email from the affiliate on 3-20-2017 no product information had been provided in relation to the anchor.
Additional Manufacturer Narrative
The complaint device was received and evaluated.Visually the device presented following anomalies: the shear pin was found to be broken, which can be attributed to excess force while operating the device handle.The rod is no longer properly engaged, resulting in the jaws failing to open and close, confirming the complaint.Further inspection revealed the rod and shaft of the manipulator was bent due to misuse.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the mitek complaints system revealed no other complaints from this lot of devices that were released for distribution.It was noted that this device is more than 3 and a half years old and possibly seen heavy use.This failure can be attributed to device misuse, where the surgeon attempted to remove the anchor and suture with excessive force rather than utilizing the device for its intended purpose.At this point in time, 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.Associated medwatch: 1221934-2017-10126, 1221934 ¿ 2017-10202.
Event or Problem Description
Affiliate reported via email during arthroscopic rotator cuff repair, suture anchor became dislodged (from osteopenic bone).During attempts by surgeon to remove the loose anchor (arthroscopically), both devices, mentioned above, were damaged and failed to open / close effectively.Need replacing.Alternate device (from competitor tray of shoulder instruments) were used to eventually remove anchor.Two minute delay.No adverse event to patient.Additional information received via email from the affiliate on 3-3-2017.The original bone hole was not used to complete the procedure.The bone hole left unfilled.Surgeon happy with repair with other anchors used.Lot numbers are as follows: ratcheted grasper - (214606) - 16j02.Suture manipulator - (214626) - 13e01.Additional information received via email from the affiliate on 3-20-2017.No product information had been provided in relation to the anchor.Additional information received via email from the affiliate on 5-4-2017.I have confirmed that it was a mitek healix peek 6.5mm anchor (ref: 222309).No record of lot number available.

• Brand Name: MANIPULATOR GRASPER
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6445066
• Report Number: 1221934-2017-10127
• Device Sequence Number: 19226754
• Product Code: HCF
• UDI-Device Identifier: 10886705004089
• UDI-Public: (01)10886705004089(10)13E01
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2017
• Report Date (Section F): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 214626
• Device Lot Number: 13E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/05/2017; 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other