MAUDE Adverse Event Report: MEDSHAPE, INC. EXOSHAPE, 11 X 30 MM; SOFT TISSUE FASTENER

Model Number 1101-00-1130

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 02/14/2013

Event Type  Injury  

Event Description

Per the (b)(4) event report submitted by the patient through the fda's medwatch program (b)(4): "exoshape fastener was used in my left tibia for an acl reconstruction.Two months after surgery, i had crippling pain in my tibia and constant swelling in my knee.I continued my rehabilitation and suffered for 9 more months before my surgeon would agree to remove it.Upon surgery, the exoshape actually popped free upon incision it was not anchored in the bone therefore pushing on my muscle, nerves and soft tissue.Immediate relief after surgery and swelling disappeared from my knee after a month." it is noted that the event date submitted by the patient actually precedes the implant date submitted, but by the patient's event description timeline of the onset of pain, the event date year should most likely be one year after that submitted by the patient.It is also noted that the implant date provided by the patient is one day earlier than the surgery date as listed on the medshape delivered goods form applicable to the subject procedure.

Manufacturer Narrative

Implant removal was completed with no issues.The device was discarded before a request for evaluation could be made, therefore, no examination was possible and a device defect could not be verified.No part numbers or lot numbers were provided, however, with the patient name and surgery date provided in the medwatch report, the delivered goods form pertaining to this surgery was identified, which contained the specific product part and lot numbers.A device history record review revealed that the lot was produced to specifications with no issues, and a review of medshape complaints and feedbacks revealed no other issues related to this lot.There is a precaution in the package insert that infers this type of event can occur: the first bullet in section 5 states, "knowledge of appropriate surgical techniques, instrumentation, proper selection placement of implants and postoperative patient care and management are essential to a successful outcome." additionally, potential adverse effects as listed in the package insert, section 6, include "loosening.Of the implant components" and "loss of fixation in bone" which "may necessitate re-operation, revision or removal surgery." the delivered goods form also included the name of the subject surgeon, who was contacted regarding this case.The subject surgeon confirmed a loosened implant upon removal, but indicated that the graft was already healed to the bone at the time of removal, such that no implant replacement was necessary.Additionally, the subject surgeon stated that the patient was seen recently and has fully recovered with no further issues.Based on the information provided, and without device evaluation, the root cause of the incident could not be determined.Based on the overall complaint rate for this failure, at this point in time, no further action is warranted, and corrective action is not indicated.However, medshape will continue to track any related complaints within this device family as means of monitoring the extent with which this complaint is observed in the field.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device thrown away by operating surgeon.

• Brand Name: EXOSHAPE, 11 X 30 MM
• Type of Device: SOFT TISSUE FASTENER
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside drive, nw; suite 440; atlanta GA 30318
• Manufacturer Contact: kenneth dupont ; 1575 northside drive, nw; suite 440; atlanta, GA 30318 ; 6782353336
• MDR Report Key: 4844233
• MDR Text Key: 18267054
• Report Number: 3007593722-2015-00001
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

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: Physician
• Device Expiration Date: 06/30/2014
• Device Model Number: 1101-00-1130
• Device Lot Number: 00251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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
• Patient Age: 47 YR