MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES, & ACC.

Catalog Number 26-1221

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Initial phone call from the customer on (b)(6) 2014, working for the purchasing department, informed that the codman disposable perforator got stuck / malfunctioned.Customer will call again with more details.(b)(6) 2014 - customer was called (purchasing department) and she mentioned that already asked the right department in the hospital to call codman for more details; however, she has not heard from them yet.

Manufacturer Narrative

(b)(4).It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information, it is not possible for codman to conduct a proper investigation.If the device is returned, the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity, a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time, this complaint is closed.Device not returned.

Manufacturer Narrative

Update:the perforators (1 used and 2 in original unopened package) were sent for evaluation and dhr review on 10/21/14.Supplier evaluation revealed that the unused perforators (2) did not verify the reported (got stuck/malfunctioned).These perforators met the functional test acceptance requirements.Proper engagement and disengagement was achieved with every drilled hole; the perforators did not get stuck in the drilled holes.Evaluation of the used perforator determined that oxidation was formed on the drill driver, bone-like debris and dried blood was also observed.The driver had a damaged groove.The deformation is comparative to that which would be seen in the perforator was subjected to repeated premature disengagement.Device history records show all tests and inspection, including a drilling test on each perforator, met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Manufacturer Narrative

The customer was contacted several times regarding product return and did not respond.The product was not returned for evaluation; therefore, it is not possible to perform an evaluation of the product and determine the root cause of this complaint.Furthermore, the lot number for the subject devise was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later time this complaint will be re-opened and an investigation will be performed.

Manufacturer Narrative

Additional info: upon completion of the investigation a follow up will be filed.

Event Description

Customer called on september 11, 2014, and provided the following additional information: disposable perforator got stuck in the skull; however, it was removed without any adverse consequences to patient and/or significant delay in surgery (less than 30 minutes) two more disposable perforators (new/never used) from the hospital stock were removed from the shelf as a precaution, as the surgeon did not feel comfortable to use them.They will be returned to codman for evaluation.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES, & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4071307
• MDR Text Key: 4739345
• Report Number: 1226348-2014-11950
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: FG001S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/11/2014; 10/02/2014; 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention