MAUDE Adverse Event Report: AESCULAP AG AND CO. KG KERRISON THIN-FT 130DG 3MM 180MM; BONE PUNCH

Model Number FF773R

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/26/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).During an operation, the screws, which fixed near handle, were loose and fell into the patient's body.The screws were picked up by the surgeon and there was no possibility that the screws remained in the pt.According to the customer, the usage time is only one time.There was a delay in procedure, length of delay not reported.

Manufacturer Narrative

Eval on-going at manufacturing site.

• Brand Name: KERRISON THIN-FT 130DG 3MM 180MM
• Type of Device: BONE PUNCH
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4688904
• MDR Text Key: 5670614
• Report Number: 2916714-2015-00327
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF773R
• Device Catalogue Number: FF773R
• Device Lot Number: 52088463
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Other