MAUDE Adverse Event Report: AESCULAP, INC. TC MAYO-HEGAR NDL HOLDERHVYSERR205MM

Model Number BM067R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2015

Event Type  malfunction  

Manufacturer Narrative

Us reporting agent notified on: (b)(6) 2015.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Loss of a piece of the jaws of the needle holder in the surgical site during the intervention.The broken piece was recovered.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 bm067r mayo-hegar needle holder.An investigation was performed visually.The metal inlay of one jaw was broken off and was not returned for evaluation.The broken segment is approximately 2 mm from the tip of the jaw.The labeling of the instrument was not completed by aesculap.Also the solder joint is not to aesculap standards.The device appears to have been repaired by a foreign company and does not meet aesculap standards.Final conclusion: complaint is not justified.The failure result is user related, using non authorized repair service.Corrective/preventive actions: not applicable.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
• Manufacturer (Section D): AESCULAP, INC.; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): AESCULAP, INC.; po box 40; tuttlingen 75801 ; GM 75801
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5032865
• MDR Text Key: 24246271
• Report Number: 2916714-2015-00730
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/23/2016

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 Model Number: BM067R
• Device Catalogue Number: BM067R
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other